Siemens Medical Solutions USA, Inc.
Knoxville, TN, US
SIEMENS MEDICAL SOLUTIONS USA, INC. appears in FDA device records in Knoxville, TN. FDA records list 829 510(k) clearances between and , 13 PMA records and 6 registered establishments. As of , FDA records show 1,268 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
7 namesFDA records resolved to Siemens Medical Solutions USA, Inc. 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.
- Cti Pet Systems, Inc.510(k), recall
- Siemans Medial Solutions USA, Increcall
- Siemens Medical Solutions USA, Inc - Radiation Oncologyrecall
- Siemens Medical Solutions USA, Inc., Concord, CArecall
- Siemens Medical Solutions USA, Inc., Mountain View, CArecall
- Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510recall
- Siemens Medical Systems, Inc.510(k), recall
510(k) clearance history
Showing 50 of 829FDA records hold 829 510(k) clearances for Siemens Medical Solutions USA, Inc. between 1980 and 2026. The busiest year on record is 2014, with 32. The most recent is 2026, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 8 |
| 1983 | 3 |
| 1984 | 2 |
| 1985 | 12 |
| 1986 | 16 |
| 1987 | 8 |
| 1988 | 5 |
| 1989 | 17 |
| 1990 | 8 |
| 1991 | 19 |
| 1992 | 14 |
| 1993 | 14 |
| 1994 | 15 |
| 1995 | 22 |
| 1996 | 22 |
| 1997 | 29 |
| 1998 | 22 |
| 1999 | 18 |
| 2000 | 22 |
| 2001 | 15 |
| 2002 | 27 |
| 2003 | 19 |
| 2004 | 30 |
| 2005 | 19 |
| 2006 | 15 |
| 2007 | 20 |
| 2008 | 10 |
| 2009 | 14 |
| 2010 | 11 |
| 2011 | 16 |
| 2012 | 19 |
| 2013 | 28 |
| 2014 | 32 |
| 2015 | 23 |
| 2016 | 21 |
| 2017 | 26 |
| 2018 | 25 |
| 2019 | 23 |
| 2020 | 32 |
| 2021 | 24 |
| 2022 | 30 |
| 2023 | 26 |
| 2024 | 23 |
| 2025 | 15 |
| 2026 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253786 | syngo.CT Coronary Cockpit | QIH | Substantially Equivalent | |
| K253678 | MAMMOMAT B.brilliant (11372950) | MUE | Substantially Equivalent | |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | KPS | Substantially Equivalent | |
| K254184 | syngo Application Software | QIH | Substantially Equivalent | |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno | OWB | Substantially Equivalent | |
| K253752 | ARTIS genio floor; ARTIS icono.explore floor | OWB | Substantially Equivalent | |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | JAK | Substantially Equivalent | |
| K254016 | MI View&GO | QIH | Substantially Equivalent | |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K250241 | Cios Select | OWB | Substantially Equivalent | |
| K251805 | syngo.CT Dual Energy | JAK | Substantially Equivalent | |
| K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K251561 | Biograph Trinion | KPS | Substantially Equivalent | |
| K251523 | Cios Spin | OWB | Substantially Equivalent | |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | JAK | Substantially Equivalent | |
| K251520 | Cios Alpha; Cios Flow | OWB | Substantially Equivalent | |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | KPS | Substantially Equivalent | |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | Substantially Equivalent | |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | JAK | Substantially Equivalent | |
| K243145 | syngo.CT LVO Detection | QAS | Substantially Equivalent | |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | JAK | Substantially Equivalent | |
| K241757 | syngo.CT Dual Energy | JAK | Substantially Equivalent | |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K243186 | Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | KPS | Substantially Equivalent | |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | OWB | Substantially Equivalent | |
| K241569 | syngo Application Software | LLZ | Substantially Equivalent | |
| K241295 | SOMATOM On.site | JAK | Substantially Equivalent | |
| K242300 | MI View&GO | QIH | Substantially Equivalent | |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBF | QIH | Substantially Equivalent | |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | IYN | Substantially Equivalent | |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | IYO | Substantially Equivalent | |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | IYN | Substantially Equivalent | |
| K232799 | syngo.via RT Image Suite | MUJ | Substantially Equivalent | |
| K232899 | AI-Rad Companion Organs RT | QKB | Substantially Equivalent | |
| K240608 | MAGNETOM Viato.Mobile | LNH | Substantially Equivalent | |
| K233657 | NAEOTOM Alpha | JAK | Substantially Equivalent | |
| K233539 | MAMMOMAT B.brilliant | MUE | Substantially Equivalent | |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | JAK | Substantially Equivalent | |
| K232431 | syngo.CT Brain Hemorrhage | QAS | Substantially Equivalent | |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X | LNH | Substantially Equivalent | |
| K233748 | CIARTIC Move (VB10) | OWB | Substantially Equivalent | |
| K232765 | MAGNETOM Cima.X Fit | LNH | Substantially Equivalent | |
| K233677 | Biograph VK10 | KPS | Substantially Equivalent | |
| K232136 | syngo.CT Applications | JAK | Substantially Equivalent | |
| K232535 | MAGNETOM Sola; MAGNETOM Altea | LNH | Substantially Equivalent | |
| K230955 | syngo Application Software | LLZ | Substantially Equivalent | |
| K231587 | MAGNETOM Cima.X | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1034973 | 1034973 | SIEMENS MEDICAL SOLUTIONS USA, INC. | 810 INNOVATION DR., KNOXVILLE, TN 37932 US | 2026 | |
| 1423253 | 1000514697 | SIEMENS MEDICAL SOLUTIONS USA, INC. | 2501 NORTH BARRINGTON RD., Hoffman Estates, IL 60192 US | 2026 | |
| 1836549 | 3003304172 | SIEMENS MEDICAL SOLUTIONS USA, INC. | 400 W. MORGAN ROAD, ANN ARBOR, MI 48108 US | 2026 | |
| 2240869 | 2240869 | SIEMENS MEDICAL SOLUTIONS USA, INC. | 40 Liberty Boulevard, Malvern, PA 19355 US | 2026 | No device listings on this registration |
| 3023245 | 3023245 | SIEMENS MEDICAL SOLUTIONS USA, INC. | 22010 S.E. 51ST ST., ISSAQUAH, WA 98029 US | 2026 | |
| 2531814 | 3002626007 | Siemens Medical Solutions USA, Inc. | 5168 Campus Dr., Plymouth Meeting, PA 19462 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- DRWAdaptor, Lead Switching, Electrocardiograph
- DRQAmplifier And Signal Conditioner, Transducer Signal
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- IXIBlock, Beam-Shaping, Radiation Therapy
- LMCCamera, Multi Format, Radiological
- DQOCatheter, Intravascular, Diagnostic
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- JAICouch, Radiation Therapy, Powered
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- LMADigitizer, Image, Radiological
- DXJDisplay, Cathode-Ray Tube, Medical
- DXKEchocardiograph
- DPSElectrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- BSZGas-Machine, Anesthesia
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- EKXHandpiece, Direct Drive, Ac-Powered
- HEMImager, Ultrasonic Obstetric-Gynecologic
- KNWInstrument, Biopsy
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- JAFMonitor, Ultrasonic, Nonfetal
- HAWNeurological Stereotaxic Instrument
- DQAOximeter
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- IXDSource, Calibration, Sealed, Nuclear
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IXKSystem, Imaging, X-Ray, Electrostatic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- KPQSystem, Simulation, Radiation Therapy
- JADSystem, Therapeutic, X-Ray
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- IZZTable, Radiographic, Non-Tilting, Powered
- IXRTable, Radiographic, Tilting
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- EHDUnit, X-Ray, Extraoral With Timer
- CADVaporizer, Anesthesia, Non-Heated
- CBKVentilator, Continuous, Facility Use
Recall records
Showing 25 of 1,268| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2648-2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen. | Class II | Open, Classified | |
| Z-2643-2026 | ARTIS icono floor. Model Number: 11327700. | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | Class II | Open, Classified | |
| Z-2642-2026 | ARTIS icono ceiling. Model Number: 11328100. | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | Class II | Open, Classified | |
| Z-2641-2026 | ARTIS icono biplane. Model Number: 11327600. | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. | Class II | Open, Classified | |
| Z-1814-2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient. | Class II | Open, Classified | |
| Z-1653-2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. | During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. | Class II | Open, Classified | |
| Z-2206-2026 | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. | Class II | Open, Classified | |
| Z-2205-2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. | Class II | Open, Classified | |
| Z-1175-2026 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02 | Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed. | Class II | Open, Classified | |
| Z-1174-2026 | Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02 | Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed. | Class II | Open, Classified | |
| Z-1242-2026 | NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | Class II | Open, Classified | |
| Z-1241-2026 | NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | Class II | Open, Classified | |
| Z-1240-2026 | NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | Class II | Open, Classified | |
| Z-1239-2026 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. | Class II | Open, Classified | |
| Z-0999-2026 | LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 | A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect. | Class II | Open, Classified | |
| Z-0879-2026 | MAMMOMAT Fusion; | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. | Class II | Open, Classified | |
| Z-0878-2026 | MAMMOMAT Inspiration; | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. | Class II | Open, Classified | |
| Z-0877-2026 | MAMMOMAT Revelation; | There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. | Class II | Open, Classified | |
| Z-0431-2026 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-2668-2025 | MAGNETOM Vida Fit. Model Number: 11410481. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-2667-2025 | MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-2666-2025 | MAGNETOM Verio Dot Upgrade. Model Number: 10684334. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-2665-2025 | MAGNETOM Verio Dot. Model Number: 10684333. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-2664-2025 | MAGNETOM Verio. Model Number: 10276755. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-2663-2025 | MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588. | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain