• 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 K203517
Device Name Saige-Q
DeepHealth, Inc.
1000 Massachusetts Ave
Cambridge,  MA  02138
Applicant Contact A. Gregory Sorensen
DeepHealth, Inc.
1000 Massachusetts Ave
Cambridge,  MA  02138
Correspondent Contact A Gregory Sorensen
Regulation Number892.2080
Classification Product Code
Date Received11/30/2020
Decision Date 04/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No