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OnSight 3D Extremity System

by Carestream Health, Inc. 2 variants

OnSight 3D Extremity System (1743566) is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K160723 on 30 Aug 2016 and listed in FDA GUDID since 19 Jan 2017 (UDI-DI 60889971743565), 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) K160723

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 Number60889971743565 UDI-DI Date19 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160723 Date30 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160723 decided 30 Aug 2016 Active
  • FDA GUDID UDI-DI 60889971743565 listed 19 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160723
  2. Listed FDA GUDID 60889971743565

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Limited-view-field CT system
Model / Ref / Catalog
OnSight 3D Extremity System, 1743566
Primary DI / UDI-DI
60889971743565
510(k) Number
FDA product code
JAK
GMDN term
Limited-view-field CT system
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Limited-view-field CT system

Cleared under the same submission (K160723)

Similar devices

Other devices filed under FDA product code JAK (System, x-ray, tomography, computed).

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)