• 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 Accelerator, Linear, Medical
510(k) Number K120067
Device Name MOSAIQ ONCOLOGY INFORMATION SYSTEM
Applicant
IMPAC MEDICAL SYSTEMS, INC.
100 MATHILDA PLACE
5TH FLOOR
SUNNYVALE,  CA  94086
Applicant Contact KATHRYN STINSON
Correspondent
IMPAC MEDICAL SYSTEMS, INC.
100 MATHILDA PLACE
5TH FLOOR
SUNNYVALE,  CA  94086
Correspondent Contact KATHRYN STINSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/09/2012
Decision Date 02/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-