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, image processing, radiological
510(k) Number K151075
Device Name BR-ABVS Viewer 1.0
Applicant
TAIHAO MEDICAL INC.
7F., NO.410, SEC.5M ZHONGXIAO E. RD., XINYI DIST.
taipei,  TW
Applicant Contact hsin hung(simon) lai
Correspondent
LIN & ASSOCIATES, LLC
9223 CAMBRIDGE MANOR COURT
potomac,  MD  20854
Correspondent Contact chiu s lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/22/2015
Decision Date 01/15/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-