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GC80

by Samsung Electronics Co., Ltd.

GC80 is a Class II device made by Samsung Electronics Co., Ltd., cleared under FDA 510(k) K143029 on 4 Feb 2015 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 08806086403467), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K143029

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806086403467 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143029 Date4 Feb 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143029 decided 4 Feb 2015 Active
  • FDA GUDID UDI-DI 08806086403467 listed 31 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0726-2018 FDA Class II initiated 22 Jun 2017

    An image was obtained with over exposure during a Thorax examination using the AEC function.

Timeline

3 dated events

  1. Cleared FDA 510(k) K143029
  2. Listed FDA GUDID 08806086403467
  3. Recall initiated FDA recalls Z-0726-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Stationary basic diagnostic x-ray system, digital
Model / reference
GC80
Primary DI / UDI-DI
08806086403467
510(k) Number
FDA product code
MQB, KPR
GMDN term
Stationary basic diagnostic x-ray system, digital
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary basic diagnostic x-ray system, digital

Similar devices in this category

Other devices filed under Stationary basic diagnostic x-ray system, digital.

Other devices from Samsung Electronics Co., Ltd.

See all devices from Samsung Electronics Co., Ltd. →

Properties

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