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 Radiological Image Processing Software For Radiation Therapy
510(k) Number K193252
Device Name Contour ProtegeAI
Applicant
MIM Software Inc.
25800 Science Park Drive - Suite 180
Cleveland,  OH  44122
Applicant Contact Lynn Hanigan
Correspondent
MIM Software Inc.
25800 Science Park Drive - Suite 180
Cleveland,  OH  44122
Correspondent Contact Lynn Hanigan
Regulation Number892.2050
Classification Product Code
QKB  
Date Received11/25/2019
Decision Date 07/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-