510(k) · Cleared
ClearedGyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 29, 1997 after a 237-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- May 29, 1997
- Review
- 237 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK963990 Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 SeriesPhilips Medical Systems, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK980645 Philips Gyroscan NT Release 6 SeriesPhilips Medical Systems North America, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK992533 Philips Gyroscan Intera (*)Philips Medical Systems North America, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK992892 Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999
- Descendant · 2 generations on · 0 of its ownK991765 Synergy Shoulder CoilPhilips Medical Systems North America, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK982834 Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc. · 1998
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980645Philips Gyroscan NT Release 6 SeriesPhilips Medical Systems North America, Inc. · 1998 · cites it directly4descendants
- K992533Philips Gyroscan Intera (*)Philips Medical Systems North America, Inc. · 1999 · 2 generations on0descendants
- K992892Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999 · 2 generations on0descendants
- K991765Synergy Shoulder CoilPhilips Medical Systems North America, Inc. · 1999 · 2 generations on0descendants
- K982834Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963990 | Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series | Philips Medical Systems, Inc. | 1997 | — |
| +1 | K980645 | Philips Gyroscan NT Release 6 Series | Philips Medical Systems North America, Inc. | 1998 | — |
| +2 | K992533 | Philips Gyroscan Intera (*) | Philips Medical Systems North America, Inc. | 1999 | — |
| +2 | K992892 | Stepping Kinematic Imaging Platform (Skip) | Magnetic Moments, LLC | 1999 | — |
| +2 | K991765 | Synergy Shoulder Coil | Philips Medical Systems North America, Inc. | 1999 | — |
| +2 | 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 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
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?
- Of its descendants, K980645 (Philips Medical Systems North America, Inc., 1998) has gone furthest, with 4 descendants of its own.
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 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/K963990 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963990: Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963990
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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