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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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
De Novo Number DEN250028
Device Name DeepView AI® System
Requester
spectralmd, inc.
2515 mckinney ave. suite 1000
dallas,  TX  75201
Contact trudy estridge
Classification Product Code
SHY
Date Received06/27/2025
Decision Date 05/21/2026
Decision granted (DENG)
Review Advisory Committee General & Plastic Surgery
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-