• 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 K213646
Device Name Focus HD 35 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 Received11/04/2021
Decision Date 03/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-