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Carestream Drx-Evolution

by Carestream Health, Inc. 10 variants

Carestream Drx-Evolution (8001174) is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K091889 on 20 Jul 2009 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 60889978001170), active (FDA 510(k)), not in commercial distribution (GUDID) as of 8 Jun 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K091889

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 Number60889978001170 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK091889 Date20 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091889 decided 20 Jul 2009 Active
  • FDA GUDID UDI-DI 60889978001170 listed 16 Sep 2016 Listed

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0797-2014 FDA Class II initiated 25 Nov 2013 on shared 510(k) K091889
    • Terminated Z-0796-2014 FDA Class II initiated 25 Nov 2013 on shared 510(k) K091889

    Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

    • Terminated Z-1877-2013 FDA Class II initiated 3 Jun 2013

    Due to potential for an x-ray exposure technique change.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K091889
  2. Recall initiated FDA recalls Z-1877-2013
  3. Recall initiated FDA recalls Z-0797-2014
  4. Recall initiated FDA recalls Z-0796-2014
  5. Listed FDA GUDID 60889978001170

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  • Withdrawn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
CARESTREAM DRX-EVOLUTION, 8001174
Primary DI / UDI-DI
60889978001170
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
Not in Commercial Distribution

Related devices

Cleared under the same submission (K091889)

and 8 more cleared under K091889

Similar devices

Other devices filed under FDA product code KPR (System, x-ray, stationary).

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

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