510(k) · Cleared
ClearedMavric SL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Dec 11, 2012 as substantially equivalent to K031230 (GE Medical Systems, 2003) after a 391-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Dec 11, 2012
- Review
- 391 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971055 (1997). 4 ancestors in all, the oldest K944979 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK971055 Diffusion Weighted MR Imaging /Magnetom VisionSiemens Medical Solutions USA, Inc. · 1997
- 2 generations backK972990 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1998
- 1 generation backK031230 GE Propeller Imaging Option for MriGE Medical Systems · 2003
- This deviceK113394 Mavric SLGe Medical Systems, LLC · 2012
- Descendant · cites it directly · 0 of its ownK143253 O-MARPhilips Medical Systems Nederland B.V. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143253O-MARPhilips Medical Systems Nederland B.V. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971055 | Diffusion Weighted MR Imaging /Magnetom Vision | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K972990 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1998 | — |
| −1 | K031230 | GE Propeller Imaging Option for Mri | GE Medical Systems | 2003 | — |
| 0 (this device) | K113394 | Mavric SL | Ge Medical Systems, LLC | 2012 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K031230 | GE Propeller Imaging Option for MriSummary page 1…Magnetic Resonance Diagnostic Device Product Code: LNH Predicate Device(s): PROPELLER Imaging Option for MRI, K03 1230 Device Description: MAVRLC SL is a software application offered as an opti… | 2003 |
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 |
|---|---|---|---|
| K143253 | O-MAR | 2015 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K143253 (Philips Medical Systems Nederland B.V., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K031230.
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. 2012, 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?
MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.OT MR systems. MAVRJC SL 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, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams. MAVRIC SL helps…
Read the full statement (132 words)
MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.OT MR systems. MAVRJC SL 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, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams.
MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRJC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation.
When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113394: Mavric SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113394
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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