R2 Studio Q/RCT820— 510(k) K222219

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K222219 for R2 Studio Q/RCT820, Substantially Equivalent on 2022-12-06. Applicant: Megagen Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Megagen Implant Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2022-07-25
Decision date: 2022-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

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