Identifiers
- 510(k) Number
- K760741 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Portable X-Ray is a mobile X-ray system designed for radiology applications. It is a Class II medical device that allows for X-ray imaging to be performed at the patient's location rather than requiring the patient to be transported to a fixed imaging facility.
The Portable X-Ray is supplied by Minxray, Inc. and has received FDA 510(k) clearance with the K number K760741. It is regulated under product code IZL and regulation number 892.1720. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the Portable X-Ray system used for?
The Portable X-Ray is a mobile X-ray system designed for radiology applications. It allows X-ray imaging to be performed at the patient's location rather than requiring transport to a fixed imaging facility.
How is the Portable X-Ray supplied and what is its regulatory status?
The Portable X-Ray is supplied by Minxray, Inc. and has received FDA 510(k) clearance with K number K760741. It is regulated under product code IZL and regulation number 892.1720.
Is the Portable X-Ray single-use or reusable?
The device is not specified as single-use or reusable in the provided information. No details regarding sterility, MRI safety, or storage conditions are available in the data.
What class of medical device is the Portable X-Ray?
The Portable X-Ray is a Class II medical device, as indicated by the FDA classification. Class II devices are those for which general controls alone are insufficient to provide reasonable assurance of safety and effectiveness.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K760741 | Class II | Active |
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Manufacturer
- Manufacturer
- Minxray, Inc.
Sources (1)
- FDA 510(k) K760741 24 fields · synced Sep 23, 2026