• 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 K171709
Device Name BR-FHUS Viewer 1.0
Applicant
TaiHao Medical Inc.
3F.-8, No.100, Sec. 2
Heping E. Rd., Da'an Dist.
taipei,  TW 10663
Applicant Contact hsin hung (simon) lai
Correspondent
Lin & Associates, LLC
5614 Johnson Avenue
bethesda,  MD  20817
Correspondent Contact chiu s. lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/08/2017
Decision Date 10/20/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-