Minxray 500M Mammographic System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K854510 FDA 510(k)
- FDA Product Code
- IZH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1710 FDA 510(k)
- Regulation Number
- 892.1710 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Minxray 500M Mammographic System is a device intended to produce radiographs of the breast. It is classified as a System, X-ray, Mammographic and may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
This device is supplied by Minxray, Inc. and is a Class II device with special controls. It received FDA 510(k) clearance on January 1, 1986, with the regulation number 892.1710. The system is intended for use in radiology settings.
Frequently asked questions
What is the Minxray 500M Mammographic System used for?
The Minxray 500M Mammographic System is a device intended to produce radiographs of the breast. It is classified as a System, X-ray, Mammographic and may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
What is the regulatory status of the Minxray 500M Mammographic System?
The Minxray 500M Mammographic System is a Class II device with special controls that received FDA 510(k) clearance on January 1, 1986, with regulation number 892.1710. It is intended for use in radiology settings.
What components are included with the Minxray 500M Mammographic System?
The Minxray 500M Mammographic System may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories as part of its complete mammographic system configuration.
Who manufactures the Minxray 500M Mammographic System?
The Minxray 500M Mammographic System is manufactured by Minxray, Inc., located at 1732 Central St., Evanston, IL 60201, with Keith R. Kretchmer as the contact person.
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: K854510 FDA 510 (k) - MINXRAY 500M MAMMOGRAPHIC SYSTEM, MINXRAY 500M MAMMOGRAPHIC SYSTEM (K854510) — FDA 510 (k) | Innolitics, MINXRAY 500M MAMMOGRAPHIC SYSTEM 510 (k) K854510 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K854510 | Class II | Active |
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Manufacturer
- Manufacturer
- Minxray, Inc.
Sources (1)
- FDA 510(k) K854510 24 fields · synced Oct 1, 2026