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FLUOROspeed 566-23000-03

by Shimadzu Corporation

FLUOROspeed 566-23000-03 is a Class II device made by Shimadzu Corporation, cleared under FDA 510(k) K191877 on 5 Aug 2019 and listed in FDA GUDID since 20 Aug 2021 (UDI-DI 04540217065271), active as of 12 Nov 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

510(k) K191877

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 Number04540217065271 UDI-DI Date20 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK191877 Date5 Aug 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191877 decided 5 Aug 2019 Active
  • FDA GUDID UDI-DI 04540217065271 listed 20 Aug 2021 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0317-2025 FDA Class II initiated 6 Sep 2024

    X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.

    • Ongoing Z-0867-2022 FDA Class II initiated 10 Jan 2022

    It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

Timeline

4 dated events

  1. Cleared FDA 510(k) K191877
  2. Listed FDA GUDID 04540217065271
  3. Recall initiated FDA recalls Z-0867-2022
  4. Recall initiated FDA recalls Z-0317-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
FLUOROspeed
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Model / reference
566-23000-03
Primary DI / UDI-DI
04540217065271
510(k) Number
FDA product code
JAA
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class II
Regulation number
892.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K191877)

Similar devices in this category

Other devices filed under Stationary general-purpose fluoroscopic x-ray system, digital.

Other devices from Shimadzu Corporation

See all devices from Shimadzu Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)