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 K210071
Device Name SIS System (Version 5.1.0)
Applicant
Surgical Information Sciences, Inc.
10405 6th Avenue N, Suite 110
Plymouth,  MN  55441
Applicant Contact Ann Quinlan-Smith
Correspondent
Hogan Lovells US LLP
1735 Market Street, 23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kelliann H. Payne
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/11/2021
Decision Date 03/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-