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N23 CCD System

by Nical SpA 57 variants

N23 CCD System (N2350NAR1) 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 9 Oct 2023 (UDI-DI 08056600520099), active as of 8 Jun 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Jun 2026

Documents

510(k) K951261

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08056600520099 UDI-DI Date9 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951261 Date15 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951261 decided 15 Mar 1996 Active
  • FDA GUDID UDI-DI 08056600520099 listed 9 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K951261
  2. Listed FDA GUDID 08056600520099

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Fluoroscopic x-ray system video image recording unit
Model / Ref / Catalog
N23, N2350NAR1
Primary DI / UDI-DI
08056600520099
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).

Other devices from Nical SpA

See all devices from Nical SpA →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)