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 Block, Beam-Shaping, Radiation Therapy
510(k) Number K091403
Device Name MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
Applicant
Oncology Tech, LLC
5608 Business Park
San Antonio,  TX  78218
Applicant Contact SEAN COMER
Correspondent
Oncology Tech, LLC
5608 Business Park
San Antonio,  TX  78218
Correspondent Contact SEAN COMER
Regulation Number892.5710
Classification Product Code
IXI  
Date Received05/12/2009
Decision Date 07/29/2009
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
-
-