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Dx-D 400 5420/101

by Agfa Corp.

Dx-D 400 5420/101 (5U68J) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K012546 on 2 Nov 2001 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904125571), 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) K012546

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 Number05414904125571 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012546 Date2 Nov 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012546 decided 2 Nov 2001 Active
  • FDA GUDID UDI-DI 05414904125571 listed 1 Sep 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0781-2024 FDA Class II initiated 13 Dec 2023

    Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

    • Terminated Z-0652-03 FDA Unclassified (pre-2012) initiated 24 Sep 2002 on shared 510(k) K012546

    Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K012546
  2. Recall initiated FDA recalls Z-0652-03
  3. Listed FDA GUDID 05414904125571
  4. Recall initiated FDA recalls Z-0781-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dx-D 400
Generic name
Stationary basic diagnostic x-ray system, digital
Model / Ref / Catalog
5420/101, 5U68J
Primary DI / UDI-DI
05414904125571
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 (K012546)

and 1 more cleared under K012546

Similar devices in this category

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

Other devices from Agfa Corp.

See all devices from Agfa Corp. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)