Identifiers
- 510(k) Number
- K173224 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 Spin-Swi is a System, Nuclear Magnetic Resonance Imaging device used in radiology. It is designed to enhance visualization of and automatically identify and quantify vascular abnormalities in the brain from MR images.
The Spin-Swi device is supplied as a software solution and has received FDA 510k clearance. It is a Class II device and is intended for use in radiology settings, with its first product receiving clearance in February 2018.
Frequently asked questions
What is the Spin-Swi device used for?
The Spin-Swi device is used to enhance visualization of and automatically identify and quantify vascular abnormalities in the brain from MR images.
Is the Spin-Swi device supplied as a software solution?
Yes, the Spin-Swi device is supplied as a software solution.
What type of clearance has the Spin-Swi device received?
The Spin-Swi device has received FDA 510k clearance and is classified as a Class II device.
In what type of setting is the Spin-Swi device intended for use?
The Spin-Swi device is intended for use in radiology settings.
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: FDA gives go-ahead for SpinTech's SPIN-SWI software, SpinTech announces 510k clearance of SPIN-SWI, Spintech Spin-Swi - allmed.wiki, K173224 - SPIN-SWI | FDA 510 (k) | Spintech, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173224 | Class II | Active |
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Manufacturer
- Manufacturer
- Spintech, Inc.
Sources (1)
- FDA 510(k) K173224 24 fields · synced Sep 26, 2026