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 K170788
Device Name CyberKnife Treatment Delivery System
Applicant
Accuray Incorportaed
1310 Chesapeake Terrace
Sunnyvale,  CA  94089
Applicant Contact Jyoti Singh
Correspondent
Accuray Incorportaed
1310 Chesapeake Terrace
Sunnyvale,  CA  94089
Correspondent Contact Jyoti Singh
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/16/2017
Decision Date 04/11/2017
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
Recalls CDRH Recalls
-
-