• 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 computer-assisted prioritization software for lesions
510(k) Number K214043
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv,  IL 6706703
Applicant Contact Nimrod Epstein
Correspondent
Hogan Lovells US LLP
555 Thirteenth St.
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QFM  
Date Received12/23/2021
Decision Date 03/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-