510(k) · Cleared
Recalled · Class II · 2023Ingenia Elition S and Ingenia Elition X R5.4
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 Mar 6, 2018 as substantially equivalent to K163116 (Philips Medical Systems Nederland B.V., 2017) after a 132-day review. Its family tree reaches back 6 generations to 2003. 4 of the 10 devices in its family, counting itself, have a Class I recall. It has been recalled 13 times.
- Decided
- Mar 6, 2018
- Review
- 132 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 6 generations to K031815 (2003). 9 ancestors in all, the oldest K001796 (2000). No later device cites it as a predicate yet. 4 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 5 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 4 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 3 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- 2 generations backK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · Recalled
- 1 generation backK163116 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · Recalled
- This deviceK173356 Ingenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −5 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −4 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −3 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| −2 | K110151 | Achieva R4 1.5T and Achieva R4 3.0T | Philips Health Care | 2011 | 20 |
| −1 | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | Philips Medical Systems Nederland B.V. | 2017 | 7 |
| 0 (this device) | K173356 | Ingenia Elition S and Ingenia Elition X R5.4 | Philips Medical Systems Nederland B.V. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
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 |
|---|---|---|---|
| * | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Summary page 5…Philips Medical Systems Nederland B.V. 510(k) Clearance: K163116 Classification Regulation: 21CFR 892.1000 Classificatio… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2023 | Class II | Z-2396-2023 | Under Investigation by firm | 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 | Under Investigation by firm | 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 diagnostics and does not impact the… |
| Jun 12, 2023 | Class II | Z-2398-2023 | Under Investigation by firm | 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 diagnostics and does not impact the… |
| Jun 12, 2023 | Class II | Z-2395-2023 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. |
| Jan 6, 2022 | Class II | Z-0974-2024 | Device Design | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field. |
| Dec 21, 2018 | Class II | Z-0922-2019 | 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-0923-2019 | 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 3, 2018 | Class II | Z-0694-2019 | Under Investigation by firm | During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. |
The 5 latest of 13 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- 3 other devices also cite its predicate K163116.
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. 2018, 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/K173356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173356: Ingenia Elition S and Ingenia Elition X R5.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173356
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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