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 K162178
Device Name CareView 1500P X-ray Flat Panel Detectors
Applicant
Careray Digital Medical System Co., Ltd.
B3-501, Biobay, 218 Xinghu St., Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact XU WEI
Correspondent
Careray Digital Medical System Co., Ltd.
B3-501, Biobay, 218 Xinghu St., Suzhou Industrial Park
Suzhou,  CN 215123
Correspondent Contact XU WEI
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/04/2016
Decision Date 09/01/2016
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
-
-