510(k) K032724

PINNACLE3 RADIATION THERAPY PLANNING SYSTEM by Adac Laboratories — Product Code MUJ

K032724 is an FDA 510(k) premarket notification submitted by Adac Laboratories for the device "PINNACLE3 RADIATION THERAPY PLANNING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 9, 2003. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Adac Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2003
Date Received
September 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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