510(k) K023052

ACUITY RADIATION THERAPY SIMULATOR by Varian Medical Systems, Inc. — Product Code KPQ

K023052 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "ACUITY RADIATION THERAPY SIMULATOR". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
September 13, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type