510(k) · Cleared
ClearedDuffusion-Weighted MR Imaging Package
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 Feb 6, 1998 as substantially equivalent to K954646 (Philips Medical Systems (Cleveland), Inc., 1996) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Feb 6, 1998
- Review
- 66 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931544 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
- 1 generation backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
- This deviceK974530 Duffusion-Weighted MR Imaging PackagePhilips Medical Systems (Cleveland), Inc. · 1998
- Descendant · cites it directly · 0 of its ownK980831 Image Post-Processing TechniquesPhilips Medical Systems (Cleveland), Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K980831Image Post-Processing TechniquesPhilips Medical Systems (Cleveland), Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931544 | 1.5T Edge and 1.0T Vista Systems | Philips Medical Systems (Cleveland), Inc. | 1993 | 2 |
| −1 | K954646 | Epi-II System Option W/High Performance Gradients | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| 0 (this device) | K974530 | Duffusion-Weighted MR Imaging Package | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| +1 | K980831 | Image Post-Processing Techniques | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K954646 | Epi-II System Option W/High Performance GradientsSummary page 2…owing table has been created to demonstrate their substantial equivalence. SUBSTANTIAL EQUIVALENCE TABLE Predicate Devices Diffusion-Weighted MR Picker EPI-II Option - K954646 Parameter Imaging Package Siemens DWI - K971055 Sequence Description Same. Echo-Planar Sequence with large magnetic field gradi… | 1996 |
| * | K971055 | Diffusion Weighted MR Imaging /Magnetom VisionSummary page 2…substantial equivalence. SUBSTANTIAL EQUIVALENCE TABLE Predicate Devices Diffusion-Weighted MR Picker EPI-II Option - K954646 Parameter Imaging Package Siemens DWI - K971055 Sequence Description Same. Echo-Planar Sequence with large magnetic field gradient pulse before and after the 180° refocusing RF… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980831 | Image Post-Processing Techniques | 1998 | 0 |
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 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K980831 (Philips Medical Systems (Cleveland), Inc., 1998) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K954646.
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 Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.
Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
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/K974530 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974530: Duffusion-Weighted MR Imaging Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974530
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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