FUJIFILM Healthcare Americas Corporation
FDA 510(k) & PMA Approved Devices — 13 products
Total Devices13
Categories9
Latest FDA decision2026-06-18
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261713 | Synapse PACS (7.6.0) | QIH | 2026-06-18 | View |
| 510(k) | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FDA | 2025-09-26 | View |
| 510(k) | K243647 | Synapse PACS (7.5) | QIH | 2025-06-30 | View |
| 510(k) | K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | FDA | 2024-06-13 | View |
| 510(k) | K233629 | APERTO Lucent MRI System | LNH | 2024-05-10 | View |
| 510(k) | K233687 | ECHELON Synergy V10.0 | LNH | 2024-05-03 | View |
| 510(k) | K233583 | FCT iSTREAM Phase 1 | JAK | 2024-04-26 | View |
| 510(k) | K240075 | FUJIFILM Endoscope Model EB-710XT | EOQ | 2024-02-07 | View |
| 510(k) | K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | ITX | 2023-12-13 | View |
| 510(k) | K231941 | ARIETTA x10 | IYN | 2023-11-20 | View |
| 510(k) | K231574 | Scenaria View 4.2 | JAK | 2023-10-12 | View |
| 510(k) | K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FED | 2023-09-15 | View |
| 510(k) | K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FDS | 2023-09-01 | View |
No matching devices.