Eup-C516
Eup-C516 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K102901 on 27 Oct 2010 (1 earlier submission) and listed in FDA GUDID since 18 Jul 2021 (UDI-DI 04573596211564), active as of 21 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04573596211564 | Date18 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102901 | Date27 Oct 2010 | StatusActive |
Official records
- AccessGUDID record 04573596211564
- FDA 510(k) database K102901
- FDA 510(k) database K093466
Across registries
- FDA 510(k) K102901 decided 27 Oct 2010 Active
- FDA GUDID UDI-DI 04573596211564 listed 18 Jul 2021 Listed
Recalls
-
- Terminated Z-2467-2011
Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead
Timeline
- Cleared FDA 510(k) K093466
- Cleared FDA 510(k) K102901
- Recall initiated FDA recalls Z-2467-2011
- Listed FDA GUDID 04573596211564
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- EUP-C516
- Primary DI / UDI-DI
- 04573596211564
- FDA product code
- IYO, IYN, ITX
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class II
- Regulation number
- 892.1560, 892.1550, 892.1570
- GUDID distribution status
- In Commercial Distribution
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