Ba-004cc
510(k) K261170
Ba-004cc is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K261170 on 12 Aug 2026, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261170 | Date12 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K261170
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITX
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K261170
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BA-004CC | BA-004CC | 04547410576610 | — | On the market |
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