• 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 analyzer, medical image
510(k) Number K232384
Device Name Videa Dental Assist
Applicant
VideaHealth, Inc.
179 South Street Floor 5
Boston,  MA  02111
Applicant Contact Adam Foresman
Correspondent
VideaHealth, Inc.
179 South Street Floor 5
Boston,  MA  02111
Correspondent Contact Adam Foresman
Regulation Number892.2070
Classification Product Code
MYN  
Date Received08/08/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-