510(k) K992753

CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM by Varian Assoc., Inc. — Product Code MUJ

K992753 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1999
Date Received
August 16, 1999
Clearance Type
Special
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