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FUJIFILM Healthcare Americas Corporation FDA Approvals
0 new drug approvals and 13 device clearances on file. Matched by name to FUJIY.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Synapse PACS (7.6.0)510(k)Jun 18, 2026Radiology |
| FUJIFILM Stiffening Wire Device (SW-2000)510(k)Sep 26, 2025Gastroenterology, Urology |
| Synapse PACS (7.5)510(k)Jun 30, 2025Radiology |
| Double Balloon Endoscope EN-840T, Over-tube TS-1214C510(k)Jun 13, 2024Gastroenterology, Urology |
| APERTO Lucent MRI System510(k)May 10, 2024Radiology |
| ECHELON Synergy V10.0510(k)May 3, 2024Radiology |
| FCT iSTREAM Phase 1510(k)Apr 26, 2024Radiology |
| FUJIFILM Endoscope Model EB-710XT510(k)Feb 7, 2024Ear, Nose, Throat |
| Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)510(k)Dec 13, 2023Radiology |
| ARIETTA x10510(k)Nov 20, 2023Radiology |
| Scenaria View 4.2510(k)Oct 12, 2023Radiology |
| Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)510(k)Sep 15, 2023Gastroenterology, Urology |
| Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)510(k)Sep 1, 2023Gastroenterology, Urology |