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, Tomography, Computed, Emission
510(k) Number K171681
Device Name Hermes Medical Imaging Suite v5.7
Applicant
Hermes Medical Solutions AB
Skeppsbron 44
Stockholm,  SE 11130
Applicant Contact Joakim Arwidson
Correspondent
Hermes Medical Solutions AB
Skeppsbron 44
Stockholm,  SE 11130
Correspondent Contact Joakim Arwidson
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/06/2017
Decision Date 11/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-