Spin-Swi
510(k) K173224
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173224 | Date23 Feb 2018 | StatusActive |
Official records
- FDA 510(k) database K173224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
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.
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- Version 4 Operating System Software by Hitachi Medical Systems America, Inc.
- MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE by Toshiba America Mri, Inc.