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 Cabinet, X-Ray System
510(k) Number K230136
Device Name TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
Applicant
CompAI Healthcare (Suzhou) Co.,ltd
Room 3A05, Building 2, No.8 Changting Road, High-tech Zone
Suzhou,  CN 215151
Applicant Contact Xueqiao Wang
Correspondent
CompAI Healthcare (Suzhou) Co.,ltd
Room 3A05, Building 2, No.8 Changting Road, High-tech Zone
Suzhou,  CN 215151
Correspondent Contact Xueqiao Wang
Regulation Number892.1680
Classification Product Code
MWP  
Date Received01/18/2023
Decision Date 04/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-