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Carestream Drx-Evolution

by Carestream Health, Inc. 10 variants

Carestream Drx-Evolution (8001232) 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 60889978001231), active as of 8 Jun 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

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 Number60889978001231 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: 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 60889978001231 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 60889978001231

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  • Withdrawn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, 8001232
Primary DI / UDI-DI
60889978001231
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 (K091889)

and 8 more cleared under K091889

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

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