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 K191384
Device Name RayCare 2.3
Applicant
RaySearch Laboratories AB (publ)
Sveavagen 44
Stockholm,  SE 11134
Applicant Contact David Hedfors
Correspondent
RaySearch Laboratories AB (publ)
Sveavagen 44
Stockholm,  SE 11134
Correspondent Contact David Hedfors
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/23/2019
Decision Date 07/08/2019
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
-
-