510(k) · Cleared
ClearedMRGP Optical Tracking Unit
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 Aug 23, 1999 as substantially equivalent to K983342 (Philips Medical Systems (Cleveland), Inc., 1998) and 1 other predicate after a 75-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Aug 23, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931544 (1993). 15 ancestors in all, the oldest K905070 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
- 4 generations backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
- 3 generations backK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
- 2 generations backK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- 1 generation backK983342 MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- This deviceK991943 MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931544 | 1.5T Edge and 1.0T Vista Systems | Philips Medical Systems (Cleveland), Inc. | 1993 | 2 |
| −4 | K954646 | Epi-II System Option W/High Performance Gradients | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −3 | K964626 | Edge/Vista System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1997 | 4 |
| −2 | K974844 | Outlook System Enhancement Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| −1 | K983342 | MR Guided Procedures (MRGP) Basic Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| 0 (this device) | K991943 | MRGP Optical Tracking Unit | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 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? (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 |
|---|---|---|---|
| * | K983342 | MR Guided Procedures (MRGP) Basic PackageSummary page 2…ial equivalence chart has been compiled to demonstrate the equivalence of the MRGP Optical Tracking Unit described in this submission with the Picker MRGP Basic Package (K983342) and the Picker ViewPoint Passive Tool Option (K990868). Substantial Equivalence Chart Parameter MRGP Optical Tracking Predicate… | 1998 |
| * | K990868 | Viewpoint Passive Tool OptionSummary page 2…he equivalence of the MRGP Optical Tracking Unit described in this submission with the Picker MRGP Basic Package (K983342) and the Picker ViewPoint Passive Tool Option (K990868). Substantial Equivalence Chart Parameter MRGP Optical Tracking Predicate Devices Unit System Compatibility Same. '| 0.23T Outloo… | 1999 |
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 6 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 3 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K983342.
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 Outlook 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.
The MRGP Optical Tracking Unit is designed to support and guide diagnostic and therapeutic interventional procedures, such as needle biopsies and drainages.
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/K991943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991943: MRGP Optical Tracking Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991943
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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