Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

K-Number: K200469 · 2020-09-16

ApplicantGenoray Co., Ltd.
Decision Date2020-09-16
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PAPAYA 3D Premium & PAPAYA 3D Premium Plus is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K200469. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K200469.

When did PAPAYA 3D Premium & PAPAYA 3D Premium Plus receive FDA 510(k) clearance?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus received FDA 510(k) clearance on 2020-09-16, under 510(k) number K200469.

Who is the listed applicant for PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

The FDA product code for PAPAYA 3D Premium & PAPAYA 3D Premium Plus is OAS.

Other records listing Genoray Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252229BELLIGER ACEK250060GT300; GT300-CK243420HESTIAK232085DVAS (DVAS-M, DVAS-W)K232158GenX-CRK230787Oscar 15 & Oscar 15i

View all 13 devices →

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑