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
-
-