• 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 K170751
Device Name MRIdian Linac System with 138-leaf Collimator
Applicant
ViewRay Incorporated
2 Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact Sean Delaney
Correspondent
ViewRay Incorporated
2 Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact Sean Delaney
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received03/13/2017
Decision Date 06/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-