N33 CCD System
N33 CCD System (N331N0ZZ1) 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 08056600520570), active as of 31 May 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 | Number08056600520570 | Date11 Oct 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK951261 | Date15 Mar 1996 | StatusActive |
Official records
- AccessGUDID record 08056600520570
- FDA 510(k) database K951261
Across registries
- FDA 510(k) K951261 decided 15 Mar 1996 Active
- FDA GUDID UDI-DI 08056600520570 listed 11 Oct 2023 Listed
Timeline
- Cleared FDA 510(k) K951261
- Listed FDA GUDID 08056600520570
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- Withdrawn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, N331N0ZZ1
- Primary DI / UDI-DI
- 08056600520570
- 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
Similar devices
Other devices filed under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).
- UNBRANDED 04-CC230 by Advance Medical Designs, Inc.
- CIOS SELECT 11515055 by Siemens Shanghai Medical Equipment Ltd.
- UNBRANDED 09-MK920 by Advance Medical Designs, Inc.
- LC POSITIONER by Fischer Imaging Corp.
- CENTRION 500 C-ARM SYSTEM by OsteoSys Co., Ltd.
- SIRESKOP CX by SIEMENS MEDICAL SOLUTIONS USA, INC.
- LP LATERAL FLUORO POSITIONER (B5077A) by General Electric Co.
- XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 by Canon Medical Systems Corporation
- LUMINOS Q.namix T 11574003 by Siemens Healthcare GmbH
- LATERAL ANGULATING FLUORO SUSPENSION by General Electric Co.