510(k) · Cleared
ClearedMR Guided Procedures (MRGP) Basic Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Dec 21, 1998 as substantially equivalent to K955389 (Siemens Medical Solutions USA, Inc., 1996) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 21, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931544 (1993). 7 ancestors in all. 4 later devices descend from it, 2 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 deviceK983342 MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · cites it directly · 2 of its ownK022007 Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK050728 Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK033353 Modification to Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK991943 MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc. · 1999
Most influential descendants
Showing 4 of 4 · See all- K022007Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2002 · cites it directly2descendants
- K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005 · 2 generations on0descendants
- K033353Modification to Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa Instruments, Inc. · 2003 · 2 generations on0descendants
- K991943MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc. · 1999 · cites it directly0descendants
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) | K983342 | MR Guided Procedures (MRGP) Basic Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +1 | K022007 | Liberty 5000 Breast Coil with Disposable Biopsy Plates | Usa Instruments, Inc. | 2002 | — |
| +2 | K050728 | Open Breast Coil (Obc) with Biopsy Plates | Usa Instruments, Inc. | 2005 | — |
| +2 | K033353 | Modification to Liberty 5000 Breast Coil with Disposable Biopsy Plates | Usa Instruments, Inc. | 2003 | — |
| +1 | K991943 | MRGP Optical Tracking Unit | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 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 |
|---|---|---|---|
| * | K955389 | MR Guided Procedures Package/Magnetom Open SystemSummary page 3…antial Equivalence Chart Parameter MR Guided Procedures Outlook System Enhancement Siemens MR Guided Procedur (MRGP) Basic Package Package (Proview) - K974844 Package - K955389 System Compatibility 0.23T Outlook, Not Applicable. 0.2T Magnetom Open 0.23T Qutlook Proview Magnet Homogeneity Same. Same. + 5 p… | 1996 |
| * | K974844 | Outlook System Enhancement PackageSummary page 3…= Page 3 === Substantial Equivalence Chart Parameter MR Guided Procedures Outlook System Enhancement Siemens MR Guided Procedur (MRGP) Basic Package Package (Proview) - K974844 Package - K955389 System Compatibility 0.23T Outlook, Not Applicable. 0.2T Magnetom Open 0.23T Qutlook Proview Magnet Homogeneity… | 1998 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K022007 (Usa Instruments, Inc., 2002) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K955389.
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
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 Basic Package is designed to support and guide diagnostic 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/K983342 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983342: MR Guided Procedures (MRGP) Basic Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983342
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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