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CR Reader CR30

by Konica Minolta Medical Imaging U.S.A., Inc.

CR Reader CR30 is a Class II device made by Konica Minolta Medical Imaging U.S.A., Inc., cleared under FDA 510(k) K062223 on 1 Sep 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817100020360), active as of 22 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 22 Oct 2026

Documents

510(k) K062223

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817100020360 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: 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 00817100020360 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062223
  2. Listed FDA GUDID 00817100020360

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CR Reader
Generic name
Digital imaging cassette/phosphor plate
Model / reference
CR30
Primary DI / UDI-DI
00817100020360
510(k) Number
FDA product code
MQB
GMDN term
Digital imaging cassette/phosphor plate
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution

Other devices from Konica Minolta Medical Imaging U.S.A., Inc.

See all devices from Konica Minolta Medical Imaging U.S.A., Inc. →

Properties

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