Cleared Traditional

PROBEAT-FR

K232032 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Radiology

Jan 2024

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K232032 is an FDA 510(k) clearance for the PROBEAT-FR, a System, Radiation Therapy, Charged-particle, Medical (Class II — Special Controls, product code LHN), submitted by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (Kashiwa-Shi, JP). The FDA issued a Cleared decision on January 12, 2024, 189 days after receiving the submission on July 7, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K232032 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2023
Decision Date	January 12, 2024
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF