# K143606: MultiBand SENSE

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nethrlands BV
- Decided: May 8, 2015 after 140 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: 5 generations back to K031815 (2003). 8 ancestors in all.
13 later devices descend from it; 1 cites it directly.
4 of 22 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 5.

## Most influential descendants
- K162940: MultiBand SENSE (2016), 12 descendants of its own
- K193215: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems (2020), 11 descendants of its own
- K212673: MR 5300 (2021), 6 descendants of its own
- K213583: Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (2022), 5 descendants of its own
- K213516: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei (2022), 5 descendants of its own

## Indications for use
MultiBand SENSE is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It’s indicated for use in magnetic resonance imaging of the brain for BOLD fMRI. MultiBand SENSE consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple volumes to accelerate imaging acquisition times or increasing coverage or resolution without increasing scan time.

Source page: https://510kreport.com/device/K143606
Methodology: https://510kreport.com/methodology
