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KDR Floor Mount System KDR FMT

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

KDR Floor Mount System KDR FMT is a Class II device made by Konica Minolta Medical Imaging U.S.A., Inc., cleared under FDA 510(k) K082604 on 21 Nov 2008 and listed in FDA GUDID since 8 Jan 2026 (UDI-DI 00817100021282), 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) K082604

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 Number00817100021282 UDI-DI Date8 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082604 Date21 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082604 decided 21 Nov 2008 Active
  • FDA GUDID UDI-DI 00817100021282 listed 8 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082604
  2. Listed FDA GUDID 00817100021282

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
KDR Floor Mount System
Generic name
Stationary basic diagnostic x-ray system, digital
Model / reference
KDR FMT
Primary DI / UDI-DI
00817100021282
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

Similar devices

Other devices filed under FDA product code KPR (System, X-Ray, Stationary).

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

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

Properties

  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)