510(k) K954467

CADPLAN BT by Varian Assoc., Inc. — Product Code JAQ

K954467 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "CADPLAN BT". The FDA issued a decision of Substantially Equivalent on March 15, 1996. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1996
Date Received
September 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type