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 K170952
Device Name syngo.CT View&GO
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd., Mail Code 65-1 A
Malvern,  PA  19355
Applicant Contact Kimberly Mangum
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd., Mail Code 65-1 A
Malvern,  PA  19355
Correspondent Contact Kimberly Mangum
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received03/31/2017
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-