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 Accelerator, Linear, Medical
510(k) Number K100096
Device Name LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
Applicant
Integra Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact HELDER A SOUSA
Correspondent
Integra Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact HELDER A SOUSA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/13/2010
Decision Date 04/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-