510(k) · Cleared
ClearedO-MAR
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 Apr 9, 2015 as substantially equivalent to K113394 (Ge Medical Systems, LLC, 2012) after a 147-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Apr 9, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971055 (1997). 5 ancestors in all, the oldest K944979 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK971055 Diffusion Weighted MR Imaging /Magnetom VisionSiemens Medical Solutions USA, Inc. · 1997
- 3 generations backK972990 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1998
- 2 generations backK031230 GE Propeller Imaging Option for MriGE Medical Systems · 2003
- 1 generation backK113394 Mavric SLGe Medical Systems, LLC · 2012
- This deviceK143253 O-MARPhilips Medical Systems Nederland B.V. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971055 | Diffusion Weighted MR Imaging /Magnetom Vision | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K972990 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1998 | — |
| −2 | K031230 | GE Propeller Imaging Option for Mri | GE Medical Systems | 2003 | — |
| −1 | K113394 | Mavric SL | Ge Medical Systems, LLC | 2012 | — |
| 0 (this device) | K143253 | O-MAR | Philips Medical Systems Nederland B.V. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K113394 | Mavric SLSummary page 5…bstantial equivalence is claimed: 1. Primary Predicate Device: MAVRIC SL Manufacturer: GE Healthcare Predicate Device k#: K113394 21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification: Summary of functions of the… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
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. 2015, 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?
O-MAR is a combination of an acquisition technique and post-processing software intended for use on Achieva and Ingenia, 1.5T & 3T MR Systems. O-MAR is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition O-MAR is suitable for use on patients without implants that are cleared for MR exams. O-MAR helps…
Read the full statement (128 words)
O-MAR is a combination of an acquisition technique and post-processing software intended for use on Achieva and Ingenia, 1.5T & 3T MR Systems. O-MAR is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition O-MAR is suitable for use on patients without implants that are cleared for MR exams. O-MAR helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus O-MAR improves visualization of more tissue in the vicinity of MR Conditional orthopedic implants. When interpreted by a trained physician, images generated by O-MAR provide information that can be useful in determining 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/K143253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143253: O-MAR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143253
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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