FUJIFILM Healthcare Americas Corporation
Lexington, MA, US
FUJIFILM Healthcare Americas Corporation appears in FDA device records in Lexington, MA. FDA records list 394 510(k) clearances between and , 8 PMA records and 5 registered establishments. As of , FDA records show 123 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
8 namesFDA records resolved to FUJIFILM Healthcare Americas Corporation 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.
- Fujifilm Medical System U.S.A., Inc.510(k), PMA, enforcement report, recall
- Fujifilm Medical Systems U.S.A, Inc.510(k), PMA, enforcement report, recall
- Fujinon, Inc.510(k), enforcement report, recall
- Hitachi Healthcare Americas Corporation510(k), enforcement report, recall
- Hitachi Medical Systems America, Inc.510(k), enforcement report, recall
- Omnyx Llcrecall
- Wako Chemicals USA, Inc.510(k), recall
- Wako Life Sciences, Inc.enforcement report, recall
510(k) clearance history
Showing 50 of 394FDA records hold 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation between 1981 and 2026. The busiest year on record is 1987, with 26. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 7 |
| 1984 | 3 |
| 1986 | 4 |
| 1987 | 26 |
| 1988 | 13 |
| 1989 | 3 |
| 1990 | 4 |
| 1991 | 8 |
| 1992 | 12 |
| 1993 | 15 |
| 1994 | 24 |
| 1995 | 20 |
| 1996 | 10 |
| 1997 | 11 |
| 1998 | 7 |
| 1999 | 14 |
| 2000 | 19 |
| 2001 | 7 |
| 2002 | 5 |
| 2003 | 8 |
| 2004 | 15 |
| 2005 | 8 |
| 2006 | 7 |
| 2007 | 8 |
| 2008 | 9 |
| 2009 | 4 |
| 2010 | 9 |
| 2011 | 18 |
| 2012 | 15 |
| 2013 | 6 |
| 2014 | 6 |
| 2015 | 12 |
| 2016 | 11 |
| 2017 | 13 |
| 2018 | 7 |
| 2019 | 5 |
| 2020 | 4 |
| 2021 | 1 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261713 | Synapse PACS (7.6.0) | QIH | Substantially Equivalent | |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FDA | Substantially Equivalent | |
| K243647 | Synapse PACS (7.5) | QIH | Substantially Equivalent | |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FDA | Substantially Equivalent | |
| K233629 | APERTO Lucent MRI System | LNH | Substantially Equivalent | |
| K233687 | ECHELON Synergy V10.0 | LNH | Substantially Equivalent | |
| K233583 | FCT iSTREAM Phase 1 | JAK | Substantially Equivalent | |
| K240075 | FUJIFILM Endoscope Model EB-710XT | EOQ | Substantially Equivalent | |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | ITX | Substantially Equivalent | |
| K231941 | ARIETTA x10 | IYN | Substantially Equivalent | |
| K231574 | Scenaria View 4.2 | JAK | Substantially Equivalent | |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FED | Substantially Equivalent | |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FDS | Substantially Equivalent | |
| K211406 | OASIS MRI System | LNH | Substantially Equivalent | |
| K202422 | Arietta 65 | IYN | Substantially Equivalent | |
| K202030 | OASIS MRI System | LNH | Substantially Equivalent | |
| K200498 | SCENARIA View | JAK | Substantially Equivalent | |
| K192851 | OASIS MRI System | LNH | Substantially Equivalent | |
| K190841 | SCENARIA View | JAK | Substantially Equivalent | |
| K191233 | ARIETTA 750 | IYN | Substantially Equivalent | |
| K190248 | ARIETTA 50 | IYN | Substantially Equivalent | |
| K183291 | Supria True64 Whole-Body X-Ray CT System | JAK | Substantially Equivalent | |
| K183456 | Aloka Arietta 850 | IYN | Substantially Equivalent | |
| K172492 | Optical Topography System ETG-4100 | DQA | Substantially Equivalent | |
| K181376 | ARIETTA 65 | IYN | Substantially Equivalent | |
| K180901 | Low Dose CT Lung Cancer Screening Option | JAK | Substantially Equivalent | |
| K173739 | ALOKA ARIETTA 850 | IYN | Substantially Equivalent | |
| K171291 | FUJIFILM Bronchoscope Model EB-530P | EOQ | Substantially Equivalent | |
| K172110 | ECHELON OVAL V6.0A MRI System | LNH | Substantially Equivalent | |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | ODG | Substantially Equivalent | |
| K171708 | ALOKA ARIETTA 850 | IYN | Substantially Equivalent | |
| K173132 | ASPIRE Cristalle | MUE | Substantially Equivalent | |
| K171463 | ASPIRE Bellus II | LLZ | Substantially Equivalent | |
| K171738 | Supria True64 | JAK | Substantially Equivalent | |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | FDT | Substantially Equivalent | |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | MQB | Substantially Equivalent | |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | FDS | Substantially Equivalent | |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | KGE | Substantially Equivalent | |
| K163675 | Processor VP-7000, Light Source BL-7000 | FET | Substantially Equivalent | |
| K170858 | FDR AQRO (DR-XD 1000) | IZL | Substantially Equivalent | |
| K162287 | Synapse 3D Perfusion Analysis | LLZ | Substantially Equivalent | |
| K170451 | FDX Console (DR-ID300CL) Software | LLZ | Substantially Equivalent | |
| K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 | JAK | Substantially Equivalent | |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | FDF | Substantially Equivalent | |
| K162079 | TRILLIUM Oval Head Coil 32 | MOS | Substantially Equivalent | |
| K161748 | SUPRIA w/guideShot Option | JAK | Substantially Equivalent | |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | KGE | Substantially Equivalent | |
| K160152 | Trillium Oval V 5.1 MRI System | LNH | Substantially Equivalent | |
| K153464 | FDR D-EVO flat Panel Detector System | MQB | Substantially Equivalent | |
| K153547 | ECHELON Oval V 5.1 MRI System | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000513161 | 1000513161 | FUJIFILM Healthcare Americas Corporation | 81 Hartwell Ave Ste 100, Lexington, MA 02421 US | 2026 | |
| 1528028 | 1528028 | FUJIFILM Healthcare Americas Corporation | 1959 Summit Commerce Park, Twinsburg, OH 44087 US | 2026 | |
| 3004972322 | 3004972322 | FUJIFILM Healthcare Americas Corporation | 79 TW Alexander Drive, Building 4501, Durham, NC 27709 US | 2026 | |
| 3005625991 | 3005625991 | FUJIFILM Healthcare Americas Corporation | 1100 King Georges Post Rd, Edison, NJ 08837 US | 2026 | and 2 more, listed in full below |
| 3008491142 | 3008491142 | FUJIFILM Healthcare Americas Corporation | 81 Hartwell Ave Ste 100, Lexington, MA 02421 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- CJAAmyloclastic, Amylase
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- EOQBronchoscope (Flexible Or Rigid)
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- FWFCamera, Television, Endoscopic, Without Audio
- IXACassette, Radiographic Film
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DAEComplement C9, Antigen, Antiserum, Control
- DQKComputer, Diagnostic, Programmable
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- FDTDuodenoscope And Accessories, Flexible/Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- FDAEnteroscope And Accessories
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- FDSGastroscope And Accessories, Flexible/Rigid
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- HIHHysteroscope (And Accessories)
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- DQAOximeter
- IXWProcessor, Radiographic-Film, Automatic
- CFPRadioimmunoassay, Immunoreactive Insulin
- EAMScreen, Intensifying, Radiographic
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IXKSystem, Imaging, X-Ray, Electrostatic
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- IZFSystem, X-Ray, Tomographic
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- ITXTransducer, Ultrasonic, Diagnostic
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
Showing 25 of 123| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3030-2026 | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | Class II | Open, Classified | |
| Z-1299-2026 | FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3) | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke. | Class II | Open, Classified | |
| Z-0044-2026 | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting. | Class II | Open, Classified | |
| Z-2219-2025 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). | Devices had an unapproved slabbing software function enabled for use. | Class II | Open, Classified | |
| Z-1407-2025 | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200. | The incorrect computed patient age is showing in VX for patients less than 3 months old. | Class II | Open, Classified | |
| Z-1898-2024 | FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33 | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury | Class II | Open, Classified | |
| Z-1884-2024 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 | AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable). | Class II | Open, Classified | |
| Z-1273-2024 | Synapse PACS - Version 7.3.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Class II | Open, Classified | |
| Z-1272-2024 | Synapse PACS - Version 7.2.200 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Class II | Open, Classified | |
| Z-1271-2024 | Synapse PACS - Version 7.2.100 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Class II | Open, Classified | |
| Z-1270-2024 | Synapse PACS - Version 7.2.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Class II | Open, Classified | |
| Z-1269-2024 | Synapse PACS - Version 7.1.000US | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Class II | Open, Classified | |
| Z-1268-2024 | Synapse PACS - Version 7.1.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | Class II | Open, Classified | |
| Z-1172-2024 | Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images. | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health. | Class II | Open, Classified | |
| Z-1171-2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images. | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health. | Class II | Open, Classified | |
| Z-3158-2024 | The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled. | When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected. | Class II | Open, Classified | |
| Z-1470-2023 | FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams | Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user. | Class II | Open, Classified | |
| Z-1750-2022 | Surpria 64: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation | Class II | Open, Classified | |
| Z-1749-2022 | Surpria: Software Version V3.11, V3.22 | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation | Class II | Open, Classified | |
| Z-1748-2022 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C | Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing the patient to additional radiation | Class II | Open, Classified | |
| Z-0192-2022 | Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 | When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual | Class II | Open, Classified | |
| Z-0191-2022 | Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual. | Class II | Open, Classified | |
| Z-0190-2022 | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual. | Class II | Open, Classified | |
| Z-0189-2022 | Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 | Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual. | Class II | Open, Classified | |
| Z-2339-2021 | OASIS MRI System | There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain