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
Device Classification Name software algorithm device to assist users in digital pathology
De Novo Number DEN200080
Device Name Paige Prostate
Requester
paige.ai
11 times square 37th floor
new york city,  NY  10036
Contact emre gulturk
Regulation Number864.3750
Classification Product Code
QPN  
Date Received12/31/2020
Decision Date 09/21/2021
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-