Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K220423
Device Name PAPAYA & PAPAYA Plus
Applicant
Genoray Co., Ltd.
#512, 560, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13230
Applicant Contact Jiyeon Lee
Correspondent
Genoray America, Inc.
147 E. Bristol Ln.
Orange,  CA  92865
Correspondent Contact Kaitlynn Min
Regulation Number872.1800
Classification Product Code
MUH  
Date Received02/14/2022
Decision Date 05/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-