MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE

• K Number: K013875
• Device Name: MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
• Manufacturer: MED-TEC,INC.
• Date Cleared: 2002-09-27 ( 308 days)
• Product Code: IXI
• Regulation Number: 892.5710
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

Software translates the ASCII output from a treatment plan to G code for use on a milling machine.

Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the MED-TEC Compensator Block Cutter Software, which indicates the device is substantially equivalent to legally marketed predicate devices. However, it does not include details on acceptance criteria, specific device performance, study methodology, sample sizes, ground truth establishment, or expert qualifications. The attachment only provides the "Indications For Use" for the software.

Regulation Number and Section

§ 892.5710 Radiation therapy beam-shaping block.

(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.