Mri Patient Positioning Devices
FDA 510(k)Class II (US FDA 510(k))
by Medtec LLC
Identifiers
- 510(k) Number
- K093738 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mri Patient Positioning Devices are used in the field of Radiology for positioning patients during Nuclear Magnetic Resonance Imaging. The device is classified as a System, Nuclear Magnetic Resonance Imaging. It is designed to facilitate patient positioning during MRI procedures. The device is used in medical settings to ensure accurate and safe positioning of patients.
The Mri Patient Positioning Devices are supplied with various registration numbers, including 3008156140, 3021593788, and 3015232217, among others. The device is regulated under the regulation number 892.1000 and has been authorized by the FDA with a 510K clearance. The device is intended for use in a medical setting, specifically in the field of Radiology. The device is designed for use with MRI systems and is subject to the applicable regulations and guidelines for such devices.
Frequently asked questions
What is the intended use of the MRI Patient Positioning Devices?
The device is intended for use in medical settings to ensure accurate and safe positioning of patients during Nuclear Magnetic Resonance Imaging procedures.
What type of clearance has the device received?
The device has received a 510K clearance from the FDA, indicating it is substantially equivalent to a predicate device.
What regulation number governs the MRI Patient Positioning Devices?
The device is regulated under the regulation number 892.1000, which pertains to Nuclear Magnetic Resonance Imaging systems.
What is the product code for the MRI Patient Positioning Devices?
The product code for the device is LNH, which is a classification code used for administrative purposes.
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 | K093738 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Medtec, Inc.
Sources (1)
- FDA 510(k) K093738 24 fields · synced Sep 23, 2026