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 K223268
Device Name BrainInsight
Applicant
Hyperfine, Inc.
351 New Whitfield St.
Guilford,  CT  06437
Applicant Contact Christine Kupchick
Correspondent
Hyperfine, Inc.
351 New Whitfield St.
Guilford,  CT  06437
Correspondent Contact Christine Kupchick
Regulation Number892.2050
Classification Product Code
QIH  
Date Received10/24/2022
Decision Date 12/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-