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CARESTREAM DRX-1 System

by Carestream Health, Inc. 7 variants

CARESTREAM DRX-1 System (8622797) is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K090318 on 6 Apr 2009 and listed in FDA GUDID since 14 May 2021 (UDI-DI 60889978622795), active as of 23 Oct 2026. 2 FDA recalls are 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

2 closed

Documents

510(k) K090318

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 Number60889978622795 UDI-DI Date14 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090318 Date6 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090318 decided 6 Apr 2009 Active
  • FDA GUDID UDI-DI 60889978622795 listed 14 May 2021 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0180-2014 FDA Class II initiated 29 Aug 2013

    Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

    • Terminated Z-2202-2012 FDA Class II initiated 12 Jun 2012

    Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

Timeline

4 dated events

  1. Cleared FDA 510(k) K090318
  2. Recall initiated FDA recalls Z-2202-2012
  3. Recall initiated FDA recalls Z-0180-2014
  4. Listed FDA GUDID 60889978622795

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Indirect flat panel x-ray detector
Model / Ref / Catalog
CARESTREAM DRX-1 System, 8622797
Primary DI / UDI-DI
60889978622795
510(k) Number
FDA product code
MQB
GMDN term
Indirect flat panel x-ray detector
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Indirect flat panel x-ray detector

Cleared under the same submission (K090318)

and 8 more cleared under K090318

Similar devices in this category

Other devices filed under Indirect flat panel x-ray detector.

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

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