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, Planning, Radiation Therapy Treatment
510(k) Number K250064
Device Name Dose+ (1.0)
Applicant
Mvision AI OY
Paciuksenkatu 29
6th Floor
Helsinki,  FI 00270
Applicant Contact Kalpana Jha
Correspondent
Mvision AI OY
Paciuksenkatu 29
6th Floor
Helsinki,  FI 00270
Correspondent Contact Kalpana Jha
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/10/2025
Decision Date 09/04/2025
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
-
-