Data / Medical devices / United States / FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation: FDA-registered device maker in Lexington, MA, United States, 4 510(k) clearances
FUJIFILM Healthcare Americas Corporation is registered with the FDA (registration 1000513161) in Lexington, MA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 26, 2025. 37 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1000513161
- Address
- 81 Hartwell Ave Ste 100, Lexington, MA, United States, 02421
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Manufacturer
- First device listed
- November 24, 2025
- Registered through
- 2026
- Brand names listed
- C9150LA, CC13HPB5, FUJIFILM Stiffening Wire Device (SW-2000), S12BP4 Neurosurgery Probe, UST-9150
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enteroscope And Accessories | FDA | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 26, 2025 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FDA | Substantially Equivalent | FUJIFILM Healthcare Americas Corporation | accessdata.fda.gov |
| August 9, 2019 | K191233 | ARIETTA 750 | IYN | Substantially Equivalent | Hitachi Healthcare Americas | accessdata.fda.gov |
| May 30, 2017 | K163505 | ARIETTA PRECISION | IYN | Substantially Equivalent | Hitachi , Ltd. | accessdata.fda.gov |
| April 12, 2013 | K122537 | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 | IYN | Substantially Equivalent | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 22, 2026 | 99529 | Class II | Ongoing | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | accessdata.fda.gov |
| January 9, 2026 | 98124 | Class II | Ongoing | 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 part | accessdata.fda.gov |
| September 15, 2025 | 97581 | Class II | Ongoing | 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. | accessdata.fda.gov |
| June 11, 2025 | 97063 | Class II | Ongoing | 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. | accessdata.fda.gov |
| February 11, 2025 | 96360 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 11, 2024 | 94443 | Class II | Ongoing | 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 examinat | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury | accessdata.fda.gov |
| April 11, 2024 | 94441 | Class II | Ongoing | 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). | accessdata.fda.gov |
| January 10, 2024 | 94090 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 3, 2024 | 93855 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 23, 2023 | 95320 | Class II | Ongoing | 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. | accessdata.fda.gov |
| February 27, 2023 | 92012 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 12, 2022 | 90751 | Class II | Ongoing | 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 | accessdata.fda.gov |
| April 30, 2021 | 87938 | Class II | Terminated | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence | accessdata.fda.gov |
| March 2, 2021 | 87579 | Class II | Ongoing | Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PA | The wrong patient information may be displayed in the viewer or PowerJacket. | accessdata.fda.gov |
| February 18, 2021 | 87507 | Class II | Terminated | TASWako Chip Cassette is part of the Wako TASWako i30 kit | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result | accessdata.fda.gov |
| December 22, 2020 | 87098 | Class III | Terminated | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) | FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing. | accessdata.fda.gov |
| December 11, 2020 | 87083 | Class II | Terminated | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM | The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user. | accessdata.fda.gov |
| September 11, 2020 | 86532 | Class II | Ongoing | Synapse PACS Software Versions 5.1 and higher | There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality. | accessdata.fda.gov |
| September 11, 2020 | 86494 | Class II | Terminated | Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. | FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected. | accessdata.fda.gov |
| May 22, 2020 | 85793 | Class II | Ongoing | Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis | accessdata.fda.gov |
| July 19, 2019 | 83524 | Class II | Terminated | Fujifilm FDR Go Plus mobile X-ray system | The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) | accessdata.fda.gov |
| January 15, 2019 | 82187 | Class II | Terminated | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposu | FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released. | accessdata.fda.gov |
| August 4, 2017 | 79078 | Class II | Terminated | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screeni | FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2, V6.0, V6.1, and V7.0, the system may a | accessdata.fda.gov |
| July 14, 2017 | 78891 | Class II | Terminated | Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and | There was a case that the swivel arm went down unintentionally when it was moved up/down. | accessdata.fda.gov |
| June 15, 2017 | 78644 | Class II | Terminated | FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal co | A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. The X-ray tube assembly in these devices is mounted to a tube mounting flange, which is part of the tube holding shaft. where cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | accessdata.fda.gov |
| September 15, 2016 | 75192 | Class II | Terminated | Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all | Image data for a patients image may not be correct | accessdata.fda.gov |
| June 9, 2016 | 74525 | Class II | Terminated | FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, | If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly. | accessdata.fda.gov |
| May 10, 2016 | 74372 | Class II | Terminated | Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS sof | Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead | accessdata.fda.gov |
| April 1, 2016 | 73668 | Class II | Terminated | Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU | Reports of failure of the device's power supply. | accessdata.fda.gov |
| February 4, 2015 | 70891 | Class II | Terminated | FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 | Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. | accessdata.fda.gov |
| February 4, 2015 | 70890 | Class II | Terminated | Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable | Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report. | accessdata.fda.gov |
| February 3, 2015 | 70854 | Class II | Terminated | Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer. | User Manual lacks a description for handling some errors even though the system can be recovered from such errors | accessdata.fda.gov |
| June 29, 2012 | 67958 | Class II | Terminated | MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator | The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2. | accessdata.fda.gov |
| February 3, 2006 | 34652 | Not yet classified | Terminated | Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS | Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset. | accessdata.fda.gov |
| September 30, 2004 | 30206 | Not yet classified | Terminated | Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 | Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use. | accessdata.fda.gov |
| May 5, 2004 | 29066 | Not yet classified | Terminated | Fuji Flash IIP and CR-IR346CL Consoles | Software: Incorrect measurement of objects within a CR image | accessdata.fda.gov |
| May 12, 2003 | 26390 | Not yet classified | Terminated | Synapse Version 2.2.1 and 2.3.1 software | Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Enteroscope And Accessories
Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.