FDA Device Registration & Listing · Lexington, MA, US · Registration 1000513161
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-06-10 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-06-10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-06-10 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-06-10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-06-10 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-06-10 |
| FDA | Enteroscope And Accessories | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-11-24 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3020707080 | FUJIFILM medwork GmbH | Hochstadt/Aisch Bavaria, DE |
| 3008787461 | FUJIFILM Imaging System (Suzhou) Co., Ltd. | Suzhou Jiangsu, CN |
| 2155 | FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office | MINAMIASHIGARA-SHI Kanagawa, JP |
| 3005625991 | FUJIFILM Healthcare Americas Corporation | Edison, NJ, US |
| 3034364687 | FUJIFILM Corporation Material Manufacturing Headquarters | Fujinomiya Shizuoka, JP |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K251204 | FUJIFILM Healthcare Americas Corporation | FUJIFILM Stiffening Wire Device (SW-2000) | 2025-09-26 |
| K233629 | FUJIFILM Healthcare Americas Corporation | APERTO Lucent MRI System | 2024-05-10 |
| K233687 | FUJIFILM Healthcare Americas Corporation | ECHELON Synergy V10.0 | 2024-05-03 |
| K231666 | FUJIFILM Healthcare Americas Corporation | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | 2023-12-13 |
| K261713 | FUJIFILM Healthcare Americas Corporation | Synapse PACS (7.6.0) | 2026-06-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0044-2026 | FUJIFILM Healthcare Americas Corporation | 2 | FDR Visionary Suite, CH-200
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33 |
| Z-1171-2024 | FUJIFILM Healthcare Americas Corporation | 2 | 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. |
| Z-1172-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical images. |
| Z-1268-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse PACS - Version 7.1.000 |
| Z-1269-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse PACS - Version 7.1.000US |
| Z-1270-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse PACS - Version 7.2.000 |
| Z-1271-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse PACS - Version 7.2.100 |
| Z-1272-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse PACS - Version 7.2.200 |
| Z-1273-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Synapse PACS - Version 7.3.000 |
| Z-1299-2026 | FUJIFILM Healthcare Americas Corporation | 2 | FDR Visionary Suite;
Model Number: CH-200;
Version: (1) 566-16130-23, (2) 566-16130-31, (3) |
| Z-1407-2025 | FUJIFILM Healthcare Americas Corporation | 2 | 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. |
| Z-1470-2023 | FUJIFILM Healthcare Americas Corporation | 2 | 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 |
| Z-1748-2022 | FUJIFILM Healthcare Americas Corporation | 2 | SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C |
| Z-1749-2022 | FUJIFILM Healthcare Americas Corporation | 2 | Surpria: Software Version V3.11, V3.22 |
| Z-1750-2022 | FUJIFILM Healthcare Americas Corporation | 2 | Surpria 64: Software Version V3.11, V3.22 |
| Z-1884-2024 | FUJIFILM Healthcare Americas Corporation | 2 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System
Model : AHM250PS24 |
| Z-1898-2024 | FUJIFILM Healthcare Americas Corporation | 2 | 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 |
| Z-2219-2025 | FUJIFILM Healthcare Americas Corporation | 3 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). |
| Z-3158-2024 | FUJIFILM Healthcare Americas Corporation | 2 | 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3008515880 | EZONO AG | Jena Thuringia, DE |
| 3029744051 | LYSIS HEALTHCARE GMBH | Graz Steiermark, AT |
| 3014574557 | ADECHOTECH | NAVEIL Loir-et-Cher, FR |
| 3012081348 | THE SENTINEL IMAGING GROUP, INC | Clarks Summit, PA, US |
| 3025786376 | ACO HEALTHCARE CO., LTD. | Taoyuan City, TW |
1000513161 when referencing this establishment in official correspondence.