Cleared Traditional

K013875 - MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE

K013875 is an FDA 510(k) clearance for MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE, manufactured by Med-Tec,Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K013875 · Med-Tec,Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
308d
Days
Class 2
Risk

K013875 is an FDA 510(k) clearance for the MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Med-Tec,Inc. (Orange City, US). The FDA issued a Cleared decision on September 27, 2002 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Med-Tec,Inc. devices

FDA 510(k) Submission Details - K013875

510(k) Number K013875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date September 27, 2002
Days to Decision 308 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 107d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXI Block, Beam-shaping, Radiation Therapy

All 21
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K013875.
VSP Bolus
K214093 · 3D Systems · Mar 2022
MODIFICATION TO ACCULEAF
K040553 · Direx Systems Corp. · Apr 2004
MICROMLC
K032790 · Siemens Medical Solutions USA, Inc. · Oct 2003
ENHANCED COMPENSATING FILTER
K000137 · Computerized Medical Systems, Inc. · Apr 2000
ANGIO-CT MIYABI
K990491 · Siemens Medical Solutions USA, Inc. · Apr 1999
ELECTRON WEDGE MODEL MT-EW-1000
K981992 · Med-Tec,Inc. · Dec 1998