510(k) · Cleared
ClearedMR-Guide 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultraguide, Ltd. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 18, 2001 as substantially equivalent to K011418 (Ultraguide, Ltd., 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 2000. 2 of the 282 devices in its family, counting itself, have a Class I recall. 279 later devices descend from it.
- Decided
- Oct 18, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002258 (2000). 2 ancestors in all. 279 later devices descend from it, 1 citing it directly. 2 of the 282 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK002258 Ultraguide CT-Guide 1010Ultraguide, Ltd. · 2000
- This deviceK013150 MR-Guide 2000Ultraguide, Ltd. · 2001
- Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Showing 5 of 279 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 279 · See all- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002258 | Ultraguide CT-Guide 1010 | Ultraguide, Ltd. | 2000 | — |
| 0 (this device) | K013150 | MR-Guide 2000 | Ultraguide, Ltd. | 2001 | — |
| +1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +2 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +4 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| +4 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 16 | 0 |
| 2016 | 16 | 0 |
| 2017 | 30 | 0 |
| 2018 | 19 | 0 |
| 2019 | 16 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 23 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 28 | 2 |
| 2026 | 22 | 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.
2 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? (2)
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 |
|---|---|---|---|
| * | K011418 | Ultraguide MR-Guide 3000Summary page 1…sification Name: Accessory for System, Nuclear Magnetic Resonance Imaging, 90 LNH, Regulation Number 892.1000 I11. Legally marketed predicate devices. A. MR-Guide 3000, K011418 B. CT-Guide 1010, K002258 IV. Description The MR-Guide 2000 provides visual guiding information of the interventional instrumen… | 2001 |
| * | K002258 | Ultraguide CT-Guide 1010Summary page 1…for System, Nuclear Magnetic Resonance Imaging, 90 LNH, Regulation Number 892.1000 I11. Legally marketed predicate devices. A. MR-Guide 3000, K011418 B. CT-Guide 1010, K002258 IV. Description The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics d… | 2000 |
What descends from it? (279)
See all 2791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053610 | Abaris | 2006 | 278 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
What does this lineage say?
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 MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. It displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs. MR-Guide 2000 system also enables monitoring the respiratory phase of the patient.
The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance imaging is currently used for visualizing such structures.
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/K013150 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013150: MR-Guide 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013150
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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