N33 CCD System
N33 CCD System (N331N2CL1) is a Class II device made by Nical SpA, cleared under FDA 510(k) K951261 on 15 Mar 1996 and listed in FDA GUDID since 11 Oct 2023 (UDI-DI 08056600520716), active as of 21 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 | Number08056600520716 | Date11 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK951261 | Date15 Mar 1996 | StatusActive |
Official records
- AccessGUDID record 08056600520716
- FDA 510(k) database K951261
Across registries
- FDA 510(k) K951261 decided 15 Mar 1996 Active
- FDA GUDID UDI-DI 08056600520716 listed 11 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K951261
- Listed FDA GUDID 08056600520716
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Fluoroscopic x-ray system video image recording unit
- Model / Ref / Catalog
- N33, N331N2CL1
- Primary DI / UDI-DI
- 08056600520716
- 510(k) Number
- FDA product code
- JAA
- GMDN term
- Fluoroscopic x-ray system video image recording unit
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
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