S12
S12 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K134016 on 28 Mar 2014 and listed in FDA GUDID since 18 Jul 2021 (UDI-DI 04573596212240), active as of 21 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04573596212240 | Date18 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK134016 | Date28 Mar 2014 | StatusActive |
Official records
- AccessGUDID record 04573596212240
- FDA 510(k) database K134016
Across registries
- FDA 510(k) K134016 decided 28 Mar 2014 Active
- FDA GUDID UDI-DI 04573596212240 listed 18 Jul 2021 Listed
Recalls
-
- Terminated Z-1341-2020
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
-
- Terminated Z-2090-2017
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Timeline
- Cleared FDA 510(k) K134016
- Recall initiated FDA recalls Z-2090-2017
- Recall initiated FDA recalls Z-1341-2020
- Listed FDA GUDID 04573596212240
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- S12
- Primary DI / UDI-DI
- 04573596212240
- 510(k) Number
- 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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