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Kalare

by Toshiba America Medical Systems, In.C

510(k) K133553

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133553 Date13 Jun 2014ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1101-2021 FDA Class II initiated 10 Dec 2020

    GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or operator.

    • Terminated Z-0012-2018 FDA Class II initiated 12 Sep 2017

    During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk.

    • Terminated Z-1175-2016 FDA Class II initiated 14 Jan 2016

    When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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