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 Digital Pathology Image Viewing And Management Software
510(k) Number K210811
Device Name Dynamyx Digital Pathology Software
Applicant
Inspirata, Inc.
One N. Dale Mabry Hwy.
Suite 600
Tampa,  FL  33609
Applicant Contact Richard Morroney
Correspondent
Inspirata, Inc.
One N. Dale Mabry Hwy.
Suite 600
Tampa,  FL  33609
Correspondent Contact Richard Morroney
Regulation Number864.3700
Classification Product Code
QKQ  
Subsequent Product Code
PSY  
Date Received03/17/2021
Decision Date 03/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-