Transducer S12BP4
by FUJIFILM Healthcare Americas Corporation
Transducer S12BP4 is a Class II device made by FUJIFILM Healthcare Americas Corporation, cleared under FDA 510(k) K122537 on 12 Apr 2013 and listed in FDA GUDID since 8 Jun 2022 (UDI-DI 00860007188343), active as of 19 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 | Number00860007188343 | Date8 Jun 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122537 | Date12 Apr 2013 | StatusActive |
Official records
- AccessGUDID record 00860007188343
- FDA 510(k) database K122537
Across registries
- FDA 510(k) K122537 decided 12 Apr 2013 Active
- FDA GUDID UDI-DI 00860007188343 listed 8 Jun 2022 Listed
Timeline
- Cleared FDA 510(k) K122537
- Listed FDA GUDID 00860007188343
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Surgical ultrasound imaging transducer
- Model / reference
- S12BP4
- Primary DI / UDI-DI
- 00860007188343
- 510(k) Number
- FDA product code
- IYO, ITX, IYN
- GMDN term
- Surgical ultrasound imaging transducer
- Device class
- Class II
- Regulation number
- 892.1560, 892.1570, 892.1550
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Hydrogen Peroxide
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Other devices filed under Surgical ultrasound imaging transducer.
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