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 K193283
Device Name AI-Rad Companion Prostate MR
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Blvd. Mail Code 65-3
Malvern,  PA  19355
Applicant Contact Lauren Bentley
Correspondent
Siemens Medical Solutions USA Inc.
40 Liberty Blvd. Mail Code 65-3
Malvern,  PA  19355
Correspondent Contact Lauren Bentley
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LNH  
Date Received11/27/2019
Decision Date 07/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-