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, Radiation Therapy, Charged-Particle, Medical
510(k) Number K134052
Device Name RADIANCE 330 PROTON THERAPY SYSTEM
Applicant
Protom International, Inc.
555 13th St. NW
Washington,  DC  20001
Applicant Contact JOHN J SMITH, MD, JD
Correspondent
Protom International, Inc.
555 13th St. NW
Washington,  DC  20001
Correspondent Contact JOHN J SMITH, MD, JD
Regulation Number892.5050
Classification Product Code
LHN  
Date Received12/31/2013
Decision Date 03/14/2014
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
-
-