Ust-568
Ust-568 is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K122341 on 26 Sep 2012 (3 earlier submissions) and listed in FDA GUDID since 17 Jul 2021 (UDI-DI 04573596212981), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04573596212981 | Date17 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122341 | Date26 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 04573596212981
- FDA 510(k) database K122341
- FDA 510(k) database K111227
- FDA 510(k) database K093488
- FDA 510(k) database K080176
Across registries
- FDA 510(k) K122341 decided 26 Sep 2012 Active
- FDA GUDID UDI-DI 04573596212981 listed 17 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K080176
- Cleared FDA 510(k) K093488
- Cleared FDA 510(k) K111227
- Cleared FDA 510(k) K122341
- Listed FDA GUDID 04573596212981
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- UST-568
- Primary DI / UDI-DI
- 04573596212981
- 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
Similar devices in this category
Other devices filed under Extracorporeal ultrasound imaging transducer, hand-held.
- SL3323 122000200 by Esaote S.p.A.
- VF10-5 Transducer 10136142 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- 14L4a Transducer 11711446 by SIEMENS MEDICAL SOLUTIONS USA, INC.
- SLAx/13-6 MHz P07699-71 by Fujifilm Sonosite, Inc.
- C1-6VN-D by GE HEALTHCARE JAPAN CORPORATION
- L 3-11 120000014 by Esaote S.p.A.
- I12C5 transducer 9034 by Bk Medical ApS
- C60xf/5-2 MHz P18024-21 by Fujifilm Sonosite, Inc.
- ML4-20VN-D 5838851 by GE Parallel Design, Inc.
- Linear Probe L14-4 A8J9 by KONICA MINOLTA, INC.