Philips North America LLC
Andover, MA, US
Philips North America LLC appears in FDA device records in Andover, MA. FDA records list 680 510(k) clearances between and , 82 PMA records and 11 registered establishments. As of , FDA records show 1,794 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
18 namesFDA records resolved to Philips North America LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Adac Laboratories510(k), recall
- Adac Labsrecall
- Capsule Tech, Inc.510(k), enforcement report, recall
- Philips Electronics North America Corp.enforcement report, recall
- Philips Healthcare Informatics, Inc.510(k), enforcement report, recall
- Philips Healthcare, Inc.510(k), enforcement report, recall
- PHILIPS HOME HEALTHCARE SOLUTIONenforcement report, recall
- Philips Medical Systems (Cleveland), Inc.registration, 510(k), PMA, enforcement report, recall
- Philips Medical Systems North America Co. Phillipsenforcement report, recall
- Philips Medical Systems North America, Inc.510(k), enforcement report, recall
- Philips Medical Systems Sales & Service Region No. Americarecall
- Philips Medical Systems, Inc.510(k), PMA, enforcement report, recall
- Philips Medical Systems, Inc. Cardiac & Monitoring Systemsrecall
- Philips Nuclear Medicine, Inc.510(k), recall
- Philips Ultrasound LLCregistration, 510(k), enforcement report, recall
- Phillips Nuclear Medicinerecall
- Stentor Inc A Phillips Medical Systems Co.recall
- Stentor, Inc.510(k), recall
510(k) clearance history
Showing 50 of 680FDA records hold 680 510(k) clearances for Philips North America LLC between 1977 and 2026. The busiest year on record is 2002, with 36. The most recent is 2026, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 6 |
| 1979 | 2 |
| 1980 | 8 |
| 1981 | 17 |
| 1982 | 6 |
| 1983 | 3 |
| 1984 | 10 |
| 1985 | 9 |
| 1986 | 10 |
| 1987 | 8 |
| 1988 | 25 |
| 1989 | 20 |
| 1990 | 14 |
| 1991 | 18 |
| 1992 | 25 |
| 1993 | 23 |
| 1994 | 19 |
| 1995 | 24 |
| 1996 | 23 |
| 1997 | 20 |
| 1998 | 35 |
| 1999 | 25 |
| 2000 | 16 |
| 2001 | 17 |
| 2002 | 36 |
| 2003 | 34 |
| 2004 | 34 |
| 2005 | 14 |
| 2006 | 18 |
| 2007 | 10 |
| 2008 | 15 |
| 2009 | 11 |
| 2010 | 8 |
| 2011 | 14 |
| 2012 | 7 |
| 2013 | 11 |
| 2014 | 7 |
| 2015 | 5 |
| 2016 | 7 |
| 2017 | 10 |
| 2018 | 6 |
| 2019 | 1 |
| 2020 | 8 |
| 2021 | 6 |
| 2022 | 1 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 13 |
| 2026 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262311 | Alturion Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K253670 | SmartCT (R3.0 (L10)) | OWB | Substantially Equivalent | |
| K260667 | Alturion Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | |
| K260123 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K252558 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K254186 | Azurion R3.1 | OWB | Substantially Equivalent | |
| K252557 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K251827 | Azurion R3.1 | OWB | Substantially Equivalent | |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K242519 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | |
| K242670 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K250030 | Flash Ultrasound System 5100 Point of Care | IYN | Substantially Equivalent | |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K241659 | Ultrasound Workspace (UWS 6.0) | QIH | Substantially Equivalent | |
| K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K242800 | The 5000 Compact Series Ultrasound Systems | IYN | Substantially Equivalent | |
| K240980 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K233545 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K232500 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K231190 | EPIQ Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K223771 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K223804 | PercuNav Image Fusion and Interventional Navigation System | JAK | Substantially Equivalent | |
| K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) | IYN | Substantially Equivalent | |
| K212777 | Collaboration Live | LLZ | Substantially Equivalent | |
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | DPS | Substantially Equivalent | |
| K203406 | Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K203231 | Switched Internal Paddles | LDD | Substantially Equivalent | |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | DPS | Substantially Equivalent | |
| K200603 | AAA Model | LLZ | Substantially Equivalent | |
| K201665 | Collaboration Live | LLZ | Substantially Equivalent | |
| K202216 | EPIQ Series Diagnostic Ultrasound Systems | IYN | Substantially Equivalent | |
| K201053 | PercuNav Image Fusion and Interventional Navigation | JAK | Substantially Equivalent | |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K192875 | Philips Biosensor BX100 | DRG | Substantially Equivalent | |
| K200304 | EPIQ Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K183387 | M3290B Patient Information Center iX | MHX | Substantially Equivalent | |
| K182926 | IntelliSpace Radiology | LLZ | Substantially Equivalent | |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3018004899 | 3018004899 | Philips Medical Systems (Cleveland), Inc. | 3630 SW 47th Avenue, Gainesville, FL 32608 US | 2026 | |
| 1218950 | 1218950 | Philips North America LLC | 3000 Minuteman Rd, ANDOVER, MA 01810 US | 2026 | and 29 more, listed in full below |
| 3006648320 | 3006648320 | Philips North America LLC | 222 Jacobs Street, Cambridge, MA 02141 US | 2026 | |
| 3012528160 | 3012528160 | Philips North America LLC | 1001 Murry Ridge Lane, Murrysville, PA 15668 US | 2026 | and 47 more, listed in full below |
| 3012607778 | 3012607778 | Philips North America LLC | 15100 Woodinville-Redmond Road NE, Woodinville, WA 98072 US | 2026 | |
| 3016618143 | 3016618143 | Philips North America LLC | 222 Jacobs Street, Cambridge, MA 02141 US | 2026 | and 50 more, listed in full below |
| 3016701404 | 3016701404 | Philips North America LLC | 1003 Corporate Lane, Export, PA 15632 US | 2026 | and 49 more, listed in full below |
| 3030677 | 1000524572 | Philips North America LLC | 22100 Bothell Everett Hwy, Bothell, WA 98021 US | 2026 | |
| 2518586 | 2518586 | Philips Ultrasound LLC | 1 Echo Dr, Reedsville, PA 17084 US | 2026 | |
| 3017894900 | 3017894900 | Philips Ultrasound LLC | 222 Jacobs Street, Cambridge, MA 02141 US | 2026 | |
| 3019216 | 3019216 | Philips Ultrasound LLC | 22100 Bothell Everett Hwy, BOTHELL, WA 98021 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRWAdaptor, Lead Switching, Electrocardiograph
- DSJAlarm, Blood-Pressure
- DRQAmplifier And Signal Conditioner, Transducer Signal
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- GWSAnalyzer, Spectrum, Electroencephalogram Signal
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- IXIBlock, Beam-Shaping, Radiation Therapy
- DXQBlood Pressure Cuff
- IKDCable, Electrode
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- BZCCalculator, Pulmonary Function Data
- CATCannula, Nasal, Oxygen
- EZLCatheter, Retention Type, Balloon
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- IXLDevice, Spot-Film
- DXJDisplay, Cathode-Ray Tube, Medical
- DXKEchocardiograph
- DPSElectrocardiograph
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- DRXElectrode, Electrocardiograph
- GWQFull-Montage Standard Electroencephalograph
- BSZGas-Machine, Anesthesia
- GWRGenerator, Electroencephalograph Test Signal
- IXYHolder, Radiographic Cassette, Wall-Mounted
- HEMImager, Ultrasonic Obstetric-Gynecologic
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- IWEMonitor, Patient Position, Light-Beam
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)
- HAWNeurological Stereotaxic Instrument
- DQAOximeter
- DSBPlethysmograph, Impedance
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- BZKSpirometer, Monitoring (W/Wo Alarm)
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- DRJSystem, Signal Isolation
- IXRTable, Radiographic, Tilting
- DRSTransducer, Blood-Pressure, Extravascular
- BXPTransducer, Gas Flow
- HFNTransducer, Pressure, Intrauterine
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- IYBTube Mount, X-Ray, Diagnostic
- FPDTube, Feeding
- CBKVentilator, Continuous, Facility Use
Recall records
Showing 25 of 1,794| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3043-2026 | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. | Class II | Open, Classified | |
| Z-3042-2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. | Class II | Open, Classified | |
| Z-3041-2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. | Class II | Open, Classified | |
| Z-3040-2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311. | Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. | Class II | Open, Classified | |
| Z-2956-2026 | Cardiac Workstation 7000. Product Number: 860441. | Device will intermittently provide inaccurate data related to native heart rate. | Class II | Open, Classified | |
| Z-2955-2026 | Cardiac Workstation 5000. Product Number: 860439. | Device will intermittently provide inaccurate data related to native heart rate. | Class II | Open, Classified | |
| Z-2652-2026 | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. | Class II | Open, Classified | |
| Z-2651-2026 | IQon Spectral CT IQon Spectral CT Upgrades | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. | Class II | Open, Classified | |
| Z-2650-2026 | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades | The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation. | Class II | Open, Classified | |
| Z-2579-2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. | Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. | Class II | Open, Classified | |
| Z-2523-2026 | Philips Avalon Fetal Monitor, FM 30 Part numberM2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | Class II | Open, Classified | |
| Z-2522-2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output. | Class II | Open, Classified | |
| Z-2354-2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. | Class II | Open, Classified | |
| Z-1969-2026 | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1968-2026 | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1967-2026 | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1966-2026 | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1965-2026 | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1964-2026 | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1963-2026 | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1962-2026 | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1961-2026 | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1960-2026 | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1959-2026 | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified | |
| Z-1958-2026 | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain