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, stationary
510(k) Number K193574
Device Name Q-Rad System
Applicant
Carestream Health, Inc.
Building 7, No. 1510 Chuanqiao Road
China (Shanghai) Pilot Free Trade Zone,  CN 201206
Applicant Contact Carolyn L Wagner
Correspondent
Carestream Health, Inc.
Building 7, No. 1510 Chuanqiao Road
China (Shanghai) Pilot Free Trade Zone,  CN 201206
Correspondent Contact Carolyn L Wagner
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
LLZ   MQB  
Date Received12/23/2019
Decision Date 01/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-