# K163116: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 6, 2017 after 60 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 7 (0 Class I)
- 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.
19 later devices descend from it; 4 cite it directly.
4 of 28 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 4.

## Most influential descendants
- K173079: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (2018), 15 descendants of its own
- K183063: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (2019), 13 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

## Recalls of this device
- Apr 14, 2026 · Class II · Z-1956-2026: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings 
- Aug 11, 2021 · Class II · Z-2417-2021: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
- Jul 30, 2021 · Class II · Z-2342-2021: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
- Jul 30, 2021 · Class II · Z-2343-2021: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
- Dec 21, 2018 · Class II · Z-0910-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Dec 21, 2018 · Class II · Z-0918-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Dec 21, 2018 · Class II · Z-0919-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

## Indications for use
This system is a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the anatomy, and the MR scan technique applied. The image acquisition process can be synchronized with the patient’s breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist the diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters, and must be controlled and validated by the clinical user. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

Source page: https://510kreport.com/device/K163116
Methodology: https://510kreport.com/methodology