510(k) · Cleared
ClearedDiffusion Package / Gyroscan NT
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 6, 1998 as substantially equivalent to K963990 (Philips Medical Systems, Inc., 1997) and 1 other predicate after a 223-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 6, 1998
- Review
- 223 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963990 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963990 Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 SeriesPhilips Medical Systems, Inc. · 1997
- This deviceK973658 Diffusion Package / Gyroscan NTPhilips Medical Systems North America, Inc. · 1998
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) | K973658 | Diffusion Package / Gyroscan NT | Philips Medical Systems North America, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K963990 | Gyroscan T5-NT, Gyroscan T10-NT and Gyroscan Acs-NT Release 5 SeriesSummary page 1…dards and/or draft standards are used. Diffusion Weighted MR Imaging. - Spin Echo (SE) and Spin Echo Echo Planar (SE-EPI) imaging Philips GYROSCAN NT systems ( FDA re. K963990). - SIEMENS Diffusion Weighted MRI / MAGNETOM Vision (FDA re.K971055). The (Extended) DIFFUSION Package provides the facility… | 1997 |
| * | K971055 | Diffusion Weighted MR Imaging /Magnetom VisionSummary page 1…- Spin Echo (SE) and Spin Echo Echo Planar (SE-EPI) imaging Philips GYROSCAN NT systems ( FDA re. K963990). - SIEMENS Diffusion Weighted MRI / MAGNETOM Vision (FDA re.K971055). The (Extended) DIFFUSION Package provides the facility of Diffusion Weighted Imaging (DWT) which generates unique contrast/inf… | 1997 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K963990.
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?
Diffusion Weighted Imaging is intended for use in generating unique contrast/information about the diffuse mobility of water or other proton containing molecules. Changes in mobility of the apparent diffusion coefficients in tissue can be seen much earlier phase than originally possible with conventional proton density, T1 or T2 weighted imaging. This change indicates neurological anomalies, of which diagnosis of acute stroke is one of the important…
Read the full statement (106 words)
Diffusion Weighted Imaging is intended for use in generating unique contrast/information about the diffuse mobility of water or other proton containing molecules. Changes in mobility of the apparent diffusion coefficients in tissue can be seen much earlier phase than originally possible with conventional proton density, T1 or T2 weighted imaging. This change indicates neurological anomalies, of which diagnosis of acute stroke is one of the important applications.
Diffusion Weighted Imaging generates contrast/information about the apparent diffusion coefficients that reflect the anisotropic nature of tissue composition (e.g. fiber tracts in brain white matter) that otherwise cannot be visualized by conventional proton density, Tl or T2 weighted imaging.
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/K973658 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973658: Diffusion Package / Gyroscan NT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973658
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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