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 K242300
Device Name MI View&GO
Applicant
Siemens Medical Solutions USA, Inc.
2501 North Barrington Road
Hoffman Estates,  IL  60192
Applicant Contact Brian Wui
Correspondent
Siemens Medical Solutions USA, Inc.
2501 North Barrington Road
Hoffman Estates,  IL  60192
Correspondent Contact Brian Wui
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/02/2024
Decision Date 08/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-