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REGIUS Plate ED64

by Konica Minolta, Inc.

REGIUS Plate ED64 is a Class II device made by Konica Minolta, Inc., cleared under FDA 510(k) K092717 on 30 Oct 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141931381), 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) K092717

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 Number04560141931381 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK092717 Date30 Oct 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092717 decided 30 Oct 2009 Active
  • FDA GUDID UDI-DI 04560141931381 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092717
  2. Listed FDA GUDID 04560141931381

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
REGIUS Plate
Generic name
Digital imaging storage phosphor screen
Model / reference
ED64
Primary DI / UDI-DI
04560141931381
510(k) Number
FDA product code
MQB
GMDN term
Digital imaging storage phosphor screen
Device class
Class II
Regulation number
892.1680
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Digital imaging storage phosphor screen

Cleared under the same submission (K092717)

and 8 more cleared under K092717

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

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