510(k) K090893

TIGRT TPS by Linatech, LLC — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2009
Date Received
March 31, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type