PAPAYA 3D & PAPAYA 3D Plus— 510(k) K220392

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K220392 for PAPAYA 3D & PAPAYA 3D Plus, Substantially Equivalent on 2022-05-19. Applicant: Genoray Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2022-02-11
Decision date: 2022-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, 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.