# K172920: 3D APT

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 22, 2018 after 119 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: 6 generations back to K031815 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
4 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163116: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3, Philips Medical Systems Nederland B.V. (2017) Summary page 5.

## Indications for use
Amide Proton Transfer weighted imaging (3D APT) is a software option intended for use on Ingenia 3.0T and Ingenia 3.0T CX MR Systems. 3D APT is indicated for use in magnetic resonance imaging of the brain. 3D APT consists of an acquisition and reconstruction technique employing frequency-selective magnetization transfer effects to derive images reflecting the spatial distribution of amide protons, and thereby protein density. 3D APT images may assist a trained physician in diagnosis and therapy planning. APTW can be combined with multi-coil acceleration approaches (SENSE).

Source page: https://510kreport.com/device/K172920
Methodology: https://510kreport.com/methodology