Small Field Applicator— 510(k) K220883

Name: FDA 510(k) clearance K220883
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Substantially Equivalent

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

FDA 510(k) clearance K220883 for Small Field Applicator, Substantially Equivalent on 2022-12-15. Applicant: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. Device class: 2.

Clearance details

Applicant: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2022-03-25
Decision date: 2022-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kashiwa-Shi, JP

Download summary PDF View on FDA.gov ↗

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