# K213516: Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei - Pathway: 510(k) (Abbreviated) - Applicant: Philips Medical Systems Nederland B.V. - Decided: Mar 3, 2022 after 120 days - Product code: LNH (System, Nuclear Magnetic Resonance Imaging) - Device class: 2 - Regulation: 21 CFR 892.1000 - Recalls of this device: 45 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 9 generations back to K031815 (2003). 14 ancestors in all. 5 later devices descend from it; 1 cites it directly. 4 of 20 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K193215: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems, Philips Medical Systems Nederland B.V. (2020) Summary page 4. ## Most influential descendants - K223442: MR 5300 and MR 7700 R11 MR Systems (2022), 4 descendants of its own - K223458: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems (2023), 2 descendants of its own - K251397: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (2025), 1 descendant of its own - K253648: Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (2026), 0 descendants of its own - K230972: Ingenia Elition and MR 7700 MR Systems (2023), 0 descendants of its own ## Recalls of this device - Aug 28, 2026 · Class II · Z-3313-2026: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is u - Aug 28, 2026 · Class II · Z-3311-2026: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is u - Aug 28, 2026 · Class II · Z-3316-2026: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is u - Aug 21, 2026 · Class II · Z-3243-2026: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system me - Aug 21, 2026 · Class II · Z-3242-2026: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system me - Aug 21, 2026 · Class II · Z-3239-2026: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system me - Apr 14, 2026 · Class II · Z-1969-2026: 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 - Apr 14, 2026 · Class II · Z-1963-2026: 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 - Dec 3, 2025 · Class II · Z-1213-2026: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Dec 3, 2025 · Class II · Z-1214-2026: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS). - Jun 30, 2025 · Class II · Z-2207-2025: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. - Jun 30, 2025 · Class II · Z-2214-2025: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire. - May 13, 2025 · Class II · Z-1792-2025: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. - May 13, 2025 · Class II · Z-1805-2025: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. - Mar 24, 2025 · Class II · Z-1776-2025: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient m - Mar 24, 2025 · Class II · Z-1783-2025: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient m - Mar 24, 2025 · Class II · Z-1772-2025: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient m - Mar 24, 2025 · Class II · Z-1782-2025: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient m - Mar 24, 2025 · Class II · Z-1770-2025: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient m - Sep 3, 2024 · Class II · Z-3202-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3201-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3203-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3204-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3193-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3205-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3198-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3196-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3200-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3199-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3194-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3195-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Sep 3, 2024 · Class II · Z-3197-2024: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal - Mar 12, 2024 · Class II · Z-1588-2024: Patient support table floor plate may be incorrectly installed. - Mar 12, 2024 · Class II · Z-1571-2024: Patient support table floor plate may be incorrectly installed. - Mar 12, 2024 · Class II · Z-1570-2024: Patient support table floor plate may be incorrectly installed. - Jan 3, 2024 · Class II · Z-0951-2024: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient m - Jun 12, 2023 · Class II · Z-2396-2023: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. - Jun 12, 2023 · Class II · Z-2399-2023: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service d - Jun 12, 2023 · Class II · Z-2398-2023: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service d - Jun 12, 2023 · Class II · Z-2395-2023: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system. - Nov 22, 2022 · Class II · Z-0459-2023: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. - Nov 22, 2022 · Class II · Z-0460-2023: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. - Nov 22, 2022 · Class II · Z-0461-2023: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. - Nov 22, 2022 · Class II · Z-0462-2023: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. - Nov 22, 2022 · Class II · Z-0463-2023: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. ## Indications for use Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing 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, the MR scan technique applied, and presence of contrast agents. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize 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 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. 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/K213516 Methodology: https://510kreport.com/methodology