Skip to content

Dx-D 60C 6007/110

by Agfa Corp.

Dx-D 60C 6007/110 (56FTB) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K142184 on 16 Oct 2014 and listed in FDA GUDID since 3 Dec 2016 (UDI-DI 05414904205273), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K142184

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 Number05414904205273 UDI-DI Date3 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142184 Date16 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142184 decided 16 Oct 2014 Active
  • FDA GUDID UDI-DI 05414904205273 listed 3 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142184
  2. Listed FDA GUDID 05414904205273

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  • Withdrawn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 60C
Generic name
Indirect flat panel x-ray detector
Model / Ref / Catalog
6007/110, 56FTB
Primary DI / UDI-DI
05414904205273
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

Similar devices in this category

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

Other devices from Agfa Corp.

See all devices from Agfa Corp. →

Properties

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