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 K851041
Device Name ADAC MODELS XL-PLAN 23 & XL-PLAN 73
Applicant
Adac Laboratories
4747 Hellyer Ave.
San Jose,  CA  95138
Applicant Contact REBECCA ANDERSEN
Correspondent
Adac Laboratories
4747 Hellyer Ave.
San Jose,  CA  95138
Correspondent Contact REBECCA ANDERSEN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/14/1985
Decision Date 07/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-