510(k) · Cleared
Recalled · Class II · 2026Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
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 Jun 4, 2025 as substantially equivalent to K223458 (Philips Medical Systems Nederland B.V., 2023) after a 29-day review. Its family tree reaches back 12 generations to 2003. 4 of the 21 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 15 times.
- Decided
- Jun 4, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 15
- Predicates
- 1
Its longest line of descent runs back 12 generations to K031815 (2003). 19 ancestors in all, the oldest K001796 (2000). 1 later device descends from it, 1 citing it directly. 4 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 8 generations between
- 3 generations backK212673 MR 5300Philips Medical Systems Nederland B.V. · 2021 · Recalled
- 2 generations backK223442 MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · 2022 · Recalled
- 1 generation backK223458 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and…Philips Medical Systems Nederland B.V. · 2023 · Recalled
- This deviceK251397 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR…Philips Medical Systems Nederland B.V. · 2025
- Descendant · cites it directly · 0 of its ownK253648 Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X…Philips Medical Systems Nederland B.V. · 2026
Show all 12 generations
- Root · 12 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
- 11 generations backK041602 Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · Recalled (Class I)
- 10 generations backK052078 Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
- 9 generations backK063559 Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Recalled (Class I)
- 8 generations backK110151 Achieva R4 1.5T and Achieva R4 3.0TPhilips Health Care · 2011 · Recalled
- 7 generations backK163116 Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3Philips Medical Systems Nederland B.V. · 2017 · Recalled
- 6 generations backK173079 Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4Philips Medical Systems Nederland B.V. · 2018 · Recalled
- 5 generations backK183063 Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V. · 2019 · Recalled
- 4 generations backK193215 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia…Philips Medical Systems Nederland B.V. · 2020 · Recalled
- 3 generations backK212673 MR 5300Philips Medical Systems Nederland B.V. · 2021 · Recalled
- 2 generations backK223442 MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V. · 2022 · Recalled
- 1 generation backK223458 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and…Philips Medical Systems Nederland B.V. · 2023 · Recalled
- This deviceK251397 Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR…Philips Medical Systems Nederland B.V. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…Philips Medical Systems Nederland B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K031815 | Intera-Sensation Family | Philips Medical Systems | 2003 | 3 |
| −11 | K041602 | Panorama 1.0T | Philips Medical Systems North America, Inc. | 2004 | Class I |
| −10 | K052078 | Achieva, Intera and Panorama 1.0 Release 2-Series | Philips Medical Systems Nederland B.V. | 2005 | Class I |
| −9 | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips Medical Systems | 2007 | Class I |
| −8 | K110151 | Achieva R4 1.5T and Achieva R4 3.0T | Philips Health Care | 2011 | 20 |
| −7 | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | Philips Medical Systems Nederland B.V. | 2017 | 7 |
| −6 | K173079 | Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 | Philips Medical Systems Nederland B.V. | 2018 | 11 |
| −5 | K183063 | Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | 2019 | 25 |
| −4 | K193215 | Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR… | Philips Medical Systems Nederland B.V. | 2020 | 152 |
| −3 | K212673 | MR 5300 | Philips Medical Systems Nederland B.V. | 2021 | 17 |
| −2 | K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | 2022 | 5 |
| −1 | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR… | Philips Medical Systems Nederland B.V. | 2023 | 17 |
| 0 (this device) | K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and… | Philips Medical Systems Nederland B.V. | 2025 | — |
| +1 | K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal… | Philips Medical Systems Nederland B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsSummary page 5…Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR System 510(k) Clearance: K223458 Manufacturer: Philips Medical Systems Nederland B.V. Classification Name:… | 2023 |
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 |
|---|---|---|---|
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR… | 2026 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2026 | Class II | Z-3313-2026 | Software design | 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 used in conjunction with third-party… |
| Aug 28, 2026 | Class II | Z-3307-2026 | Software design | 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 used in conjunction with third-party… |
| Aug 28, 2026 | Class II | Z-3312-2026 | Software design | 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 used in conjunction with third-party… |
| Aug 28, 2026 | Class II | Z-3311-2026 | Software design | 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 used in conjunction with third-party… |
| Aug 28, 2026 | Class II | Z-3310-2026 | Software design | 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 used in conjunction with third-party… |
| Aug 28, 2026 | Class II | Z-3315-2026 | Software design | 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 used in conjunction with third-party… |
| Aug 28, 2026 | Class II | Z-3318-2026 | Software design | 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 used in conjunction with third-party… |
| Apr 14, 2026 | Class II | Z-1968-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1958-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1969-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1954-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1961-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1965-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1964-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
| Apr 14, 2026 | Class II | Z-1962-2026 | Under Investigation by firm | 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 in the default MRE scan protocol… |
The 5 latest of 15 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 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 6 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 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 19 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K253648 (Philips Medical Systems Nederland B.V., 2026) has gone furthest, with 0 descendants of its own.
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. 2025, 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?
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…
Read the full statement (282 words)
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 bv the clinical user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251397: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251397
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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