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RADspeed Pro 503-79460-01

by Shimadzu Corporation

RADspeed Pro 503-79460-01 is a Class II device made by Shimadzu Corporation, cleared under FDA 510(k) K152244 on 20 Jun 2016 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04540217052356), active as of 12 Nov 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K152244; other models may be affected

Documents

510(k) K152244

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04540217052356 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK152244 Date20 Jun 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152244 decided 20 Jun 2016 Active
  • FDA GUDID UDI-DI 04540217052356 listed 16 Sep 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2294-2026 FDA Class II initiated 20 Apr 2026 on shared 510(k) K152244

    Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.

    • Terminated Z-2654-2017 FDA Class II initiated 23 May 2017

    Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K152244
  2. Listed FDA GUDID 04540217052356
  3. Recall initiated FDA recalls Z-2654-2017
  4. Recall initiated FDA recalls Z-2294-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RADspeed Pro
Generic name
Stationary basic diagnostic x-ray system, digital
Model / reference
503-79460-01
Primary DI / UDI-DI
04540217052356
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

Related devices

Category: Stationary basic diagnostic x-ray system, digital

Cleared under the same submission (K152244)

and 8 more cleared under K152244

Similar devices in this category

Other devices filed under Stationary basic diagnostic x-ray system, digital.

Other devices from Shimadzu Corporation

See all devices from Shimadzu Corporation →

Properties

  • Combination product
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)