PAPAYA 3D Premium & PAPAYA 3D Premium Plus— 510(k) K200469

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K200469 for PAPAYA 3D Premium & PAPAYA 3D Premium Plus, Substantially Equivalent on 2020-09-16. Applicant: Genoray Co., Ltd..

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2020-02-26
Decision date: 2020-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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