C015 Fp Xl C015
C015 Fp Xl C015 is a Class II device made by Micronica SRL, cleared under FDA 510(k) K192182 on 17 Jan 2020 and listed in FDA GUDID since 16 Mar 2020 (UDI-DI 08053470960017), 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 | Number08053470960017 | Date16 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192182 | Date17 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 08053470960017
- FDA 510(k) database K192182
Across registries
- FDA 510(k) K192182 decided 17 Jan 2020 Active
- FDA GUDID UDI-DI 08053470960017 listed 16 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K192182
- Listed FDA GUDID 08053470960017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- C015
- Generic name
- Diagnostic x-ray digital imaging system workstation
- Model / reference
- FP XL C015
- Primary DI / UDI-DI
- 08053470960017
- 510(k) Number
- FDA product code
- OWB
- GMDN term
- Diagnostic x-ray digital imaging system workstation
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
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