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 System, Image Processing, Radiological
510(k) Number K202718
Device Name Qmenta Care Platform Family
Applicant
Mint Labs, Inc., D/B/A. Qmenta
One International Place, Suite 3700
Boston,  MA  02110
Applicant Contact Paulo Rodrigues
Correspondent
Qmenta Imaging S.L.
C/ Roger De Lluria 46, Pral. 1 08009
Barcelona,  ES 08009
Correspondent Contact Paulo Rodrigues
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/17/2020
Decision Date 06/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-