Med-Tec Breast Support System
FDA 510(k)Class II (US FDA 510(k))
by Medtec LLC
Identifiers
- 510(k) Number
- K942282 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the Med-Tec Breast Support System primarily used for in clinical settings?
The Med-Tec Breast Support System is designed to provide support and positioning for breast tissue during radiologic imaging procedures, such as mammography. Its purpose is to minimize movement and ensure consistent positioning, which helps improve the accuracy and quality of diagnostic imaging.
Is the Med-Tec Breast Support System intended for single-use or reusable applications?
The Med-Tec Breast Support System is explicitly described as a reusable medical accessory. It is intended for use in radiology settings and should be handled according to standard medical device protocols, though no specific cleaning or sterilization instructions are provided in the available data.
What regulatory pathway was followed for FDA clearance of the Med-Tec Breast Support System?
The Med-Tec Breast Support System received FDA 510(k) clearance under the product code IYE, with a decision date of July 18, 1994. The clearance was granted through a traditional review process, and the device was determined to be substantially equivalent to a predicate device. The submission was filed under the Radiology advisory committee (RA).
Are there any specific storage instructions provided for the Med-Tec Breast Support System?
The available data does not provide specific storage instructions beyond standard medical device handling protocols. Users should follow general guidelines for maintaining reusable medical devices in a clean, dry environment to ensure proper functionality and hygiene.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medtec Med-Tec Breast Support - allmed.wiki, MED-TEC BREAST SUPPORT SYSTEM (K942282) — FDA 510(k) | Innolitics, MED-TEC BREAST SUPPORT SYSTEM 510 (k) K942282 - FDA.report, PDF K942282 - Med-tec Breast Support System, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K942282 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Medtec, Inc.
Sources (1)
- FDA 510(k) K942282 24 fields · synced Sep 19, 2026