510(k) · Cleared
Recalled · Class II · 2025Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 6, 2017 as substantially equivalent to K063559 (Philips Medical Systems, 2007) after a 79-day review. Its family tree reaches back 4 generations to 2003. 4 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 21 times.
- Decided
- Jan 6, 2017
- Review
- 79 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031815 (2003). 7 ancestors in all, the oldest K001796 (2000). 1 later device descends from it, 1 citing it directly. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 3 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 2 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 1 generation backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- This deviceK162931 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3Philips Medical Systems Nederland B.V. · 2017
- Descendant · cites it directly · 0 of its ownK173507 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4Philips Healthcare (Suzhou) Co., Ltd. · 2018
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K173507Prodiva 1.5T CX and Prodiva 1.5T CS R5.4Philips Healthcare (Suzhou) Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −3 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −2 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −1 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| 0 (this device) | K162931 | Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 | Philips Medical Systems Nederland B.V. | 2017 | — |
| +1 | K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | Philips Healthcare (Suzhou) Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5Summary page 4…nufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K063559 (01/04/2007) Classification Regulation: 21 CFR, Part 892.1000 Classification… | 2007 |
| † | K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | 2016 |
| † | K110151 | Achieva R4 1.5T and Achieva R4 3.0T | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173507 | Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | 2018 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2025 | Class II | Z-1788-2025 | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| May 13, 2025 | Class II | Z-1791-2025 | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| May 13, 2025 | Class II | Z-1790-2025 | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| May 13, 2025 | Class II | Z-1789-2025 | Software design | Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. |
| Oct 23, 2023 | Class II | Z-0393-2024 | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. |
| Oct 23, 2023 | Class II | Z-0389-2024 | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. |
| Oct 23, 2023 | Class II | Z-0390-2024 | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. |
| Oct 23, 2023 | Class II | Z-0392-2024 | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. |
| Oct 23, 2023 | Class II | Z-0394-2024 | Under Investigation by firm | Potential component failure in the Gradient Coil could product smoke and/or fire. |
| Aug 11, 2021 | Class II | Z-2415-2021 | Device Design | 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 |
| Aug 11, 2021 | Class II | Z-2414-2021 | Device Design | 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 |
| Aug 11, 2021 | Class II | Z-2420-2021 | Device Design | 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 |
| Aug 11, 2021 | Class II | Z-2412-2021 | Device Design | 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 |
| Aug 11, 2021 | Class II | Z-2421-2021 | Device Design | 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-2345-2021 | Nonconforming Material/Component | 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-2341-2021 | Nonconforming Material/Component | 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-0901-2019 | Unknown/Undetermined by firm | 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-0904-2019 | Unknown/Undetermined by firm | 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-0902-2019 | Unknown/Undetermined by firm | 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. |
| Mar 16, 2018 | Class II | Z-1436-2018 | Nonconforming Material/Component | Potential risk for helium gas inside the MR examination room during a magnet quench |
| Mar 16, 2018 | Class II | Z-1437-2018 | Nonconforming Material/Component | Potential risk for helium gas inside the MR examination room during a magnet quench |
The 5 latest of 21 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 7 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K173507 (Philips Healthcare (Suzhou) Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K063559.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
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…
Read the full statement (266 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162931: Ingenia 1.5T CX and Ingenia 3.0T CX R5.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162931
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026