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 K101220
Device Name EXPLORER 4D TREATMENT PLANNING SYSTEM
Applicant
AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO,  CA  92128
Applicant Contact DAN OLIVER
Correspondent
AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO,  CA  92128
Correspondent Contact DAN OLIVER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/03/2010
Decision Date 11/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-