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 K243350
Device Name Rapid Neuro3D
Applicant
Ischemaview, Inc.
1120 Washington Ave.
Suite 200 Rm.108
Golden,  CO  80401
Applicant Contact Patricia Setti-LaPerch
Correspondent
Ischemaview, Inc.
1120 Washington Ave.
Suite 200 Rm.108
Golden,  CO  80401
Correspondent Contact Patricia Setti-LaPerch
Regulation Number892.2050
Classification Product Code
QIH  
Date Received10/28/2024
Decision Date 01/22/2025
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
-
-