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 Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K221345
Device Name Wireless Digital Flat Panel Detector
Applicant
iRay Technology Taicang Ltd.
No.33 Xinggang Rd., Taicang Port Economic
Technological Development Zone
Taicang,  CN 215434
Applicant Contact Junjie Qian
Correspondent
iRay Technology Taicang Ltd.
No.33 Xinggang Rd., Taicang Port Economic
Technological Development Zone
Taicang,  CN 215434
Correspondent Contact Junjie Qian
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/09/2022
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-