Skip to content

CARESTREAM DRX-1 System

by Carestream Health, Inc. 7 variants

CARESTREAM DRX-1 System (1035153) 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 16 Sep 2016 (UDI-DI 60889971035158), active as of 8 Jun 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 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60889971035158 UDI-DI Date16 Sep 2016ListedStatusListed 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 60889971035158 listed 16 Sep 2016 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 60889971035158

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  • Withdrawn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, 1035153
Primary DI / UDI-DI
60889971035158
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)