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 Automated Radiological Image Processing Software
510(k) Number K203785
Device Name ClariSIGMAM
Applicant
ClariPi Inc.
3F, 70-15, Ihwajang-gil
Seoul,  KR 03088
Applicant Contact Hyun-Sook Park
Correspondent
ClariPi Detroit Office
1645 Park Creek Ct. Rochester Hills
Detroit,  MI  48309
Correspondent Contact Harry Park
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/28/2020
Decision Date 09/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-