Cs-7 Afep
Cs-7 Afep is a Class II device made by Konica Minolta, Inc., cleared under FDA 510(k) K241319 on 21 Nov 2024 and listed in FDA GUDID since 17 Jun 2026 (UDI-DI 04560141952140), 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 | Number04560141952140 | Date17 Jun 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241319 | Date21 Nov 2024 | StatusActive |
Official records
- AccessGUDID record 04560141952140
- FDA 510(k) database K241319
Across registries
- FDA 510(k) K241319 decided 21 Nov 2024 Active
- FDA GUDID UDI-DI 04560141952140 listed 17 Jun 2026 Listed
Timeline
- Cleared FDA 510(k) K241319
- Listed FDA GUDID 04560141952140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cs-7
- Generic name
- Diagnostic x-ray digital imaging system workstation application software
- Model / reference
- AFEP
- Primary DI / UDI-DI
- 04560141952140
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Diagnostic x-ray digital imaging system workstation application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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