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8622359

by Carestream Health, Inc.

8622359 is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K201373 on 26 Jun 2020 and listed in FDA GUDID since 14 Dec 2020 (UDI-DI 60889978622351), 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

1 ongoing

This device is named in the recall

Documents

510(k) K201373

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 Number60889978622351 UDI-DI Date14 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK201373 Date26 Jun 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201373 decided 26 Jun 2020 Active
  • FDA GUDID UDI-DI 60889978622351 listed 14 Dec 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1206-2023 FDA Class II initiated 30 Jan 2023

    After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury

Timeline

3 dated events

  1. Cleared FDA 510(k) K201373
  2. Listed FDA GUDID 60889978622351
  3. Recall initiated FDA recalls Z-1206-2023

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  • Withdrawn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 / Ref / Catalog
8622359
Primary DI / UDI-DI
60889978622351
510(k) Number
FDA product code
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

Cleared under the same submission (K201373)

and 8 more cleared under K201373

Similar devices in this category

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

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)