PROBEAT-V— 510(k) K152592

Substantially Equivalent

Hitachi, Ltd., Health Care Company

FDA 510(k) clearance K152592 for PROBEAT-V, Substantially Equivalent on 2015-11-02. Applicant: Hitachi, Ltd., Health Care Company. Device class: 2.

Clearance details

Applicant: Hitachi, Ltd., Health Care Company
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2015-09-10
Decision date: 2015-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHN

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K243900 — eMotus Respiratory Motion Management System2025-06-27

More clearances from Hitachi, Ltd., Health Care Company

K153614 — PROBEAT-V and accessories2016-04-21
K152207 — Extended Range Shifter for PROBEAT-V2015-10-02
K151132 — PROBEAT-V2015-06-01

Recalls naming K152592

K-number listed on FDA's recall record

Z-1892-2019 — PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.Class II·Terminated·Hitachi America, Ltd., Power Systems Division·20190415

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152592.

Data sourced from openFDA. This site is unofficial and independent of the FDA.