Identifiers
- 510(k) Number
- K202518 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 Promaxo MRI System is an open MRI system designed to image the internal structures of the body. It is a Class 2 device with product code LNH, intended for use in physician's offices without requiring considerable facility upgrades. The system features a limited footprint and fringe field, allowing it to be easily moved and placed inside a standard office.
The system consists of a magnet cart housing the magnet, gradient coils, and radiofrequency (RF) coil. It is FDA 510(k) cleared with K202518, cleared through the Traditional 510(k) pathway after a 183-day FDA review. The device is manufactured by Promaxo, Inc. and is designed for MRI-guided prostate biopsy in a standard exam room.
Frequently asked questions
What is the Promaxo MRI System designed for?
The Promaxo MRI System is an open MRI system designed for MRI-guided prostate biopsy in standard exam rooms. It features a limited footprint and fringe field, allowing it to be easily placed inside a standard office without requiring considerable facility upgrades.
How is the Promaxo MRI System supplied?
The system consists of a magnet cart housing the magnet, gradient coils, and radiofrequency (RF) coil. It is designed to be easily moved and placed inside a standard exam room, making it suitable for physician's offices without requiring significant facility modifications.
What is the regulatory status of the Promaxo MRI System?
The Promaxo MRI System is FDA 510(k) cleared with K202518, cleared through the Traditional 510(k) pathway after a 183-day FDA review. It is classified as a Class 2 device with product code LNH and is intended for use in physician's offices.
What are the key features of the Promaxo MRI System?
The system features a limited footprint and fringe field, allowing it to be easily moved and placed inside a standard office. It is designed for MRI-guided prostate biopsy and consists of a magnet cart housing the magnet, gradient coils, and radiofrequency (RF) coil.
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: Promaxo MRI System - medical-xprt.com, K202518 FDA 510 (k) - Promaxo MRI System | Promaxo, Inc., Promaxo - The MRI That Moved Into the Urologist's Office
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202518 | Class II | Active |
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Manufacturer
- Manufacturer
- Promaxo, Inc.
Sources (1)
- FDA 510(k) K202518 24 fields · synced Sep 24, 2026