510(k) K013875

MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE by Med-Tec,Inc. — Product Code IXI

K013875 is an FDA 510(k) premarket notification submitted by Med-Tec,Inc. for the device "MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE". The FDA issued a decision of Substantially Equivalent on September 27, 2002. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Med-Tec,Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2002
Date Received
November 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type