PROBEAT-CR— 510(k) K201042

Substantially Equivalent

Hitachi , Ltd.

FDA 510(k) clearance K201042 for PROBEAT-CR, Substantially Equivalent on 2020-07-13. Applicant: Hitachi , Ltd.. Device class: 2.

Clearance details

Applicant: Hitachi , Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2020-04-20
Decision date: 2020-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kashiwa-Shi, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Hitachi , Ltd.

K191801 — PROBEAT-CR2019-09-13
K172087 — SANGRAY2017-10-27
K163505 — ARIETTA PRECISION2017-05-30
K162902 — ARIETTA Prologue Diagnostic Ultrasound system and Transducers2016-12-15
K162583 — ALOKA LISENDO 8802016-11-17

Recalls naming K201042

K-number listed on FDA's recall record

Z-1430-2026 — Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRClass II·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·20260206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201042.

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