# K131241: SWIP

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 30, 2013 after 121 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: 8 generations back to K971684 (1997). 31 ancestors in all.
5 later devices descend from it; 2 cite it directly.
9 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110151: Achieva R4 1.5T and Achieva R4 3.0T, Philips Health Care (2011) Summary page 3.
- K083147: Discovery MR450, Ge Medical Systems, LLC (2008) Summary page 2.
- K050200: Magnetom Trio a Tim System, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K173224: Spin-Swi (2018), 3 descendants of its own
- 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
- K210415: QSM software, QSMetric (2021), 0 descendants of its own

## Indications for use
SWIp is a software option intended for use on Achieva and Ingenia I15T & 3.OT MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presenting susceptibility differences, such as dleoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information, SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

Source page: https://510kreport.com/device/K131241
Methodology: https://510kreport.com/methodology