510(k) · Cleared
Recalled · Class II · 2013Infinion 0.6T MR Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 22, 2002 as substantially equivalent to K974844 (Philips Medical Systems (Cleveland), Inc., 1998) after a 62-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 22, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931544 (1993). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
- 3 generations backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
- 2 generations backK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
- 1 generation backK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- This deviceK013858 Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002
- Descendant · cites it directly · 4 of its ownK024042 Panorama EnhancementsPhilips Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 3 of its ownK071154 Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007
- Descendant · 3 generations on · 0 of its ownK131737 Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK092237 NSM-S15 SystemNeusoft Medical Systems Co., Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK082485 Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2008
Most influential descendants
Showing 5 of 5 · See all- K024042Panorama EnhancementsPhilips Medical Systems, Inc. · 2003 · cites it directly4descendants
- K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007 · 2 generations on3descendants
- K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd. · 2014 · 3 generations on0descendants
- K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd. · 2009 · 3 generations on0descendants
- K082485Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931544 | 1.5T Edge and 1.0T Vista Systems | Philips Medical Systems (Cleveland), Inc. | 1993 | 2 |
| −3 | K954646 | Epi-II System Option W/High Performance Gradients | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −2 | K964626 | Edge/Vista System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1997 | 4 |
| −1 | K974844 | Outlook System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| 0 (this device) | K013858 | Infinion 0.6T MR Imaging System | Philips Medical Systems (Cleveland), Inc. | 2002 | — |
| +1 | K024042 | Panorama Enhancements | Philips Medical Systems, Inc. | 2003 | — |
| +2 | K071154 | Superstar 0.35T Mri System | Neusoft Medical Systems Co., Ltd. | 2007 | — |
| +3 | K131737 | Supernova C5 Mri System | Liaoning Kampo Medical System Co., Ltd. | 2014 | — |
| +3 | K092237 | NSM-S15 System | Neusoft Medical Systems Co., Ltd. | 2009 | — |
| +3 | K082485 | Modification to Superopen 0.23T Mri System, Model Nam-P023A | Neusoft Medical Systems Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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.
Planning a device in LNH? 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 |
|---|---|---|---|
| * | K974844 | Outlook System Enhancement PackageSummary page 2…o demonstrate their substantial equivalence. Substantial Equivalence Chart Predicate Device — Philips | Parameter Infinion 0.6T MR Imaging System Proview 0.23T System (K974844 Display/database system: | Same. Single display for system operation and image reviewing, workstation tower, moveable keyboard an… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024042 | Panorama Enhancements | 2003 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2013 | Class II | Z-0033-2014 | Device Design | There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system. |
| Sep 19, 2008 | Not classified | Z-2434-2010 | Other | Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K024042 (Philips Medical Systems, Inc., 2003) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K974844.
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.
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?
The Infinion 0.6T MR Imaging System does not change the existing indications as defined below.
The Infinion 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013858: Infinion 0.6T MR Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013858
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026