# K173224: Spin-Swi

- Pathway: 510(k) (Traditional)
- Applicant: Spintech, Inc.
- Decided: Feb 23, 2018 after 143 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 32 ancestors in all.
3 later devices descend from it; 2 cite it directly.
9 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131241: SWIP, Philips Medical Systems Nederland B.V. (2013) Summary page 4.

## Most influential descendants
- K210843: STAGE (2021), 1 descendant of its own
- K223079: Stage (2022), 0 descendants of its own
- K203279: Veuron-Brain-mN1 (2022), 0 descendants of its own

## Indications for use
The SpinTech, Inc. SPIN-SWI application is intended for use in the post-acquisition image enhancement of MRI acquired 3D gradient-echo images of the brain. When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis by providing enhanced visualization of structures containing venous blood such as cerebral venous vasculature.

Source page: https://510kreport.com/device/K173224
Methodology: https://510kreport.com/methodology