PAPAYA 3D Plus— 510(k) K150354

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K150354 for PAPAYA 3D Plus, Substantially Equivalent on 2015-12-10. Applicant: Genoray Co., Ltd..

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2015-02-11
Decision date: 2015-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-City, KR

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