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 K233582
Device Name Rapid
Applicant
iSchema View Inc.
1120 Washington Ave., Ste 200
Golden,  CO  80401
Applicant Contact Dr. Subok Park
Correspondent
iSchema View Inc.
1120 Washington Ave., Ste 200
Golden,  CO  80401
Correspondent Contact Jim Rosa
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received11/02/2023
Decision Date 04/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-