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Med-Tec Breast Support System

by Medtec LLC

510(k) K942282

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK942282 Date18 Jul 1994ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IYE
FDA applicant
Medtec, Inc.
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Med-Tec Breast Support System is a Class II medical device designed to provide support and positioning for breast tissue during radiologic imaging procedures. It is intended to minimize movement and ensure consistent positioning, improving the accuracy and quality of diagnostic imaging such as mammography or other radiologic studies.

This device is supplied as a reusable medical accessory and is intended for use in radiology settings. It has received FDA 510(k) clearance under the product code IYE, with a decision date of July 18, 1994. The system is not described as MRI-safe or single-use in the available data, and no specific sterility or storage instructions are provided beyond standard medical device handling protocols.

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

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