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Cr MD4.0T Plate 18X24

by Agfa Corp.

Cr MD4.0T Plate 18X24 (E4VCK) is a Class II device made by Agfa Corp., cleared under FDA 510(k) K062223 on 1 Sep 2006 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05414904027998), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

510(k) K062223

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 Number05414904027998 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK062223 Date1 Sep 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062223 decided 1 Sep 2006 Active
  • FDA GUDID UDI-DI 05414904027998 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062223
  2. Listed FDA GUDID 05414904027998

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cr MD4.0T Plate
Generic name
Digital imaging cassette/phosphor plate
Model / Ref / Catalog
CR MD4.0T PLATE 18X24, E4VCK
Primary DI / UDI-DI
05414904027998
FDA product code
MQB
GMDN term
Digital imaging cassette/phosphor plate
Device class
Class II
Regulation number
892.1680
GUDID distribution status
Not in Commercial Distribution
Size
Width — 24 Centimeter
Length — 18 Centimeter

Similar devices in this category

Other devices filed under Digital imaging cassette/phosphor plate.

Other devices from Agfa Corp.

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)