# Spin-Swi

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/spin-swi-lnh>
- Manufacturer: [Spintech, Inc.](https://devicerts.com/manufacturers/spintech-inc) (United States, FDA 510(k) applicant)
- Name in the registry: SPIN-SWI
- Device class: Class II (US FDA)
- FDA product code: LNH

## Overview

*AI-generated summary, 2026-09-26. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K173224 · decision 2018-02-23 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K173224 [FDA 510(k)]
- FDA product code: LNH [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1000 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Spin-Swi, Spintech, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/spin-swi-lnh (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/spin-swi-lnh.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/spin-swi-lnh
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.