# K123492: DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Dec 13, 2012 after 30 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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.
1 later device descends from it; 1 cites it directly.
4 of 10 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)

## Most influential descendants
- K254190: dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T (2026), 0 descendants of its own

## Indications for use
The Ingenia 1.5T and Ingenia 3.0T are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis. In addition, the Ingenia 1.5T and Ingenia 3.0T devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.

Source page: https://510kreport.com/device/K123492
Methodology: https://510kreport.com/methodology