Cleared Traditional

Small Field Applicator

K220883 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Radiology

Dec 2022

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K220883 is an FDA 510(k) clearance for the Small Field Applicator, 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 December 15, 2022, 265 days after receiving the submission on March 25, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K220883 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2022
Decision Date	December 15, 2022
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF