• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K041577
Device Name PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Original Applicant
ADAC LABORATORIES
6400 enterprise lane,ste.201
madison,  WI  53719
Original Contact randy vader
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MUJ  
Date Received06/14/2004
Decision Date 06/25/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-