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Probeat-Fr

by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

510(k) K232032

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

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 NumberK232032 Date12 Jan 2024ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

    • Ongoing Z-1429-2026 FDA Class II initiated 6 Feb 2026

    Software anomaly in the patient positioning system may result in positional discrepancy.

  • 3 recalls, same reason

    • Ongoing Z-3126-2024 FDA Class II initiated 27 May 2024
    • Ongoing Z-3125-2024 FDA Class II initiated 27 May 2024
    • Ongoing Z-3127-2024 FDA Class II initiated 27 May 2024

    During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

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  • Withdrawn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
LHN
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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