ELECTRON WEDGE MODEL MT-EW-1000

• K Number: K981992
• Device Name: ELECTRON WEDGE MODEL MT-EW-1000
• Manufacturer: MED-TEC,INC.
• Date Cleared: 1998-12-15 ( 190 days)
• Product Code: IXI
• Regulation Number: 892.5710
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The intended use of this device is to help provide dose uniformity for electron beam profile.

Device Description

MED-TEC, INC. has a Block, Beam-Shaping, Radiation system to be manufactured by MED-TEC, INC.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the "Electron Wedge MT-EW-1000" by Med-Tec, Inc. It indicates that the device has been found substantially equivalent to a predicate device and can therefore be marketed.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. It is purely a regulatory clearance notice.

Therefore, I cannot provide the requested information from the given input.

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.