510(k) · Cleared
ClearedPhilips Gyroscan NT Release 6 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 11, 1998 as substantially equivalent to K963990 (Philips Medical Systems, Inc., 1997) after an 81-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963990 (1997). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK963990 Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 SeriesPhilips Medical Systems, Inc. · 1997
- This deviceK980645 Philips Gyroscan NT Release 6 SeriesPhilips Medical Systems North America, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK992533 Philips Gyroscan Intera (*)Philips Medical Systems North America, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK992892 Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999
- Descendant · cites it directly · 0 of its ownK991765 Synergy Shoulder CoilPhilips Medical Systems North America, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK982834 Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K992533Philips Gyroscan Intera (*)Philips Medical Systems North America, Inc. · 1999 · cites it directly0descendants
- K992892Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999 · cites it directly0descendants
- K991765Synergy Shoulder CoilPhilips Medical Systems North America, Inc. · 1999 · cites it directly0descendants
- K982834Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963990 | Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series | Philips Medical Systems, Inc. | 1997 | — |
| 0 (this device) | K980645 | Philips Gyroscan NT Release 6 Series | Philips Medical Systems North America, Inc. | 1998 | — |
| +1 | K992533 | Philips Gyroscan Intera (*) | Philips Medical Systems North America, Inc. | 1999 | — |
| +1 | K992892 | Stepping Kinematic Imaging Platform (Skip) | Magnetic Moments, LLC | 1999 | — |
| +1 | K991765 | Synergy Shoulder Coil | Philips Medical Systems North America, Inc. | 1999 | — |
| +1 | K982834 | Restgrid Package/Gyroscan NT | Philips Medical Systems North America, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 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 |
|---|---|---|---|
| * | K963990 | Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 SeriesSummary page 1…ards and/or draft standards are used. Common/Usual Name : Philips Gyroscan NT(*) Release 6 series. Predicate Device(s) : Philips Gyroscan NT Release 5 series (FDA re.K963990). Intended Use : The Philips Gyroscan NT Release 6 series have the same intended use as its predecessor and predicate device Gy… | 1997 |
What descends from it? (4)
4 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?
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 Philips Gyroscan NT Release 6 series have the same intended use as its predecessor and predicate device Gyroscan NT Release 5. The GYROSCAN NT systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and *'P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in 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/K980645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980645: Philips Gyroscan NT Release 6 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980645
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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