C9150LA
by FUJIFILM Healthcare Americas Corporation
C9150LA is a Class II device made by FUJIFILM Healthcare Americas Corporation, cleared under FDA 510(k) K163505 on 30 May 2017 and listed in FDA GUDID since 1 Jul 2021 (UDI-DI 00860007188305), active as of 22 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 | Number00860007188305 | Date1 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163505 | Date30 May 2017 | StatusActive |
Official records
- AccessGUDID record 00860007188305
- FDA 510(k) database K163505
Across registries
- FDA 510(k) K163505 decided 30 May 2017 Active
- FDA GUDID UDI-DI 00860007188305 listed 1 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
- Recall initiated FDA recalls Z-2090-2017
- Cleared FDA 510(k) K163505
- Recall initiated FDA recalls Z-1341-2020
- Listed FDA GUDID 00860007188305
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Surgical ultrasound imaging transducer
- Model / reference
- C9150LA
- Primary DI / UDI-DI
- 00860007188305
- 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
Similar devices in this category
Other devices filed under Surgical ultrasound imaging transducer.
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