Company ยท US
FUJIFILM Healthcare Americas Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (1 in 12 months)
24recalls (2 in 12 months)
23recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 6 |
| JAK | System, X-Ray, Tomography, Computed | 5 |
| KPR | System, X-Ray, Stationary | 3 |
| FDA | Enteroscope And Accessories | 2 |
| IZL | System, X-Ray, Mobile | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 |
| QIH | Automated Radiological Image Processing Software | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| OTE | Digital Breast Tomosynthesis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K261713 | Synapse PACS (7.6.0) FUJIFILM Healthcare Americas Corporation | QIH |
| Sep 26, 2025 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) FUJIFILM Healthcare Americas Corporation | FDA |
| Jun 30, 2025 | K243647 | Synapse PACS (7.5) FUJIFILM Healthcare Americas Corporation | QIH |
| Jun 13, 2024 | K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C FUJIFILM Healthcare Americas Corporation | FDA |
| May 10, 2024 | K233629 | APERTO Lucent MRI System FUJIFILM Healthcare Americas Corporation | LNH |
| May 3, 2024 | K233687 | ECHELON Synergy V10.0 FUJIFILM Healthcare Americas Corporation | LNH |
| Apr 26, 2024 | K233583 | FCT iSTREAM Phase 1 FUJIFILM Healthcare Americas Corporation | JAK |
| Feb 7, 2024 | K240075 | FUJIFILM Endoscope Model EB-710XT FUJIFILM Healthcare Americas Corporation | EOQ |
| Dec 13, 2023 | K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) FUJIFILM Healthcare Americas Corporation | ITX |
| Nov 20, 2023 | K231941 | ARIETTA x10 FUJIFILM Healthcare Americas Corporation | IYN |
| Oct 12, 2023 | K231574 | Scenaria View 4.2 FUJIFILM Healthcare Americas Corporation | JAK |
| Sep 15, 2023 | K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) FUJIFILM Healthcare Americas Corporation | FED |
| Sep 1, 2023 | K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) FUJIFILM Healthcare Americas Corporation | FDS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2026 | FUJIFILM Healthcare Americas Corporation FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Open, Classified |
LLZ | K190232 |
| Feb 5, 2026 | FUJIFILM Healthcare Americas Corporation FDR Visionary Suite;
Model Number: CH-200;
Version: (1) 566-16130-23, (2) 566-16130-31, (3) Open, Classified |
KPR | K152294 |
| Oct 7, 2025 | FUJIFILM Healthcare Americas Corporation FDR Visionary Suite, CH-200
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 Open, Classified |
KPR | K152294 |
| Jul 30, 2025 | FUJIFILM Healthcare Americas Corporation ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). Open, Classified |
OTE | None listed |
| Mar 20, 2025 | FUJIFILM Healthcare Americas Corporation 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. Open, Classified |
LLZ | K160108 K190232 |
| Sep 25, 2024 | FUJIFILM Healthcare Americas Corporation 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. Open, Classified |
IZL | K170858 |
| May 24, 2024 | FUJIFILM Healthcare Americas Corporation 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 Open, Classified |
KPR | K152294 |
| May 22, 2024 | FUJIFILM Healthcare Americas Corporation Noblus AC Adapter used with the Noblus Ultrasound Imaging System
Model : AHM250PS24 Open, Classified |
IYN | K160559 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.3.000 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.200 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.100 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.2.000 Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.1.000US Open, Classified |
LLZ | K190232 |
| Mar 7, 2024 | FUJIFILM Healthcare Americas Corporation Synapse PACS - Version 7.1.000 Open, Classified |
LLZ | K190232 |
| Feb 21, 2024 | FUJIFILM Healthcare Americas Corporation Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical images. Open, Classified |
LLZ | K151859 |
| Feb 21, 2024 | FUJIFILM Healthcare Americas Corporation 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. Open, Classified |
LLZ | K190232 |
| Apr 27, 2023 | FUJIFILM Healthcare Americas Corporation 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 Open, Classified |
IZL | K170858 |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation Surpria 64: Software Version V3.11, V3.22 Open, Classified |
JAK | K183291 |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation Surpria: Software Version V3.11, V3.22 Open, Classified |
JAK | K183291 |
| Jul 12, 2022 | FUJIFILM Healthcare Americas Corporation SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C Open, Classified |
JAK | K213829 |
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Arietta 65 Ultrasound
Software Versions: V1.0 through V4.0.0 Open, Classified |
IYN | K181376 |
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Lisendo 880 Ultrasound
Software Version: V1.0 through V4.1.3 Open, Classified |
IYN | K162583 |
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Arietta 850 Ultrasound-
Software Version: V1.0.0 through V4.1.3 Open, Classified |
IYN | K171708 K173739 +1 |
| Oct 14, 2021 | FujiFilm Healthcare Americas Corporation Arietta 750 Ultrasound
Software Version: V1.0.0 through V2.1.3 Open, Classified |
IYN | K191233 |