510(k) · Cleared
ClearedImage Post-Processing Techniques
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 Aug 27, 1998 as substantially equivalent to K960265 (GE Medical Systems, 1996) and 2 other predicates after a 176-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Aug 27, 1998
- Review
- 176 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K913475 (1991). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 2 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 1 generation backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- This deviceK980831 Image Post-Processing TechniquesPhilips Medical Systems (Cleveland), Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −2 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −1 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K980831 | Image Post-Processing Techniques | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K960265 | Advantage Windows with Functool OptionSummary page 2…a pixel-by-pixel basis or region of interest « Time intensity information in plot or tabular form Predicate Devices Parameter Image Post-Processing GE FuncTool Option (K960265), Techniques Philips Quantitative Anal. (K971965), Diffusion Imaging (K974530), Compatibility Same. Available on Independent Work… | 1996 |
| * | K971965 | Philips EasyvisionSummary page 2…ime intensity information in plot or tabular form Predicate Devices Parameter Image Post-Processing GE FuncTool Option (K960265), Techniques Philips Quantitative Anal. (K971965), Diffusion Imaging (K974530), Compatibility Same. Available on Independent Workstations or the MR System Operator’s Console (See… | 1998 |
| * | K974530 | Duffusion-Weighted MR Imaging PackageSummary page 2…plot or tabular form Predicate Devices Parameter Image Post-Processing GE FuncTool Option (K960265), Techniques Philips Quantitative Anal. (K971965), Diffusion Imaging (K974530), Compatibility Same. Available on Independent Workstations or the MR System Operator’s Console (See K960265) Inputs * MR images… | 1998 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 12 other devices also cite its predicate K960265.
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 intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below. ProPak Techniques The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged. Diffusion Coefficient Mapping The Picker…
Read the full statement (162 words)
The intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below.
ProPak Techniques
The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged.
Diffusion Coefficient Mapping
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. Post-processing using ADC mapping produces parametric images with further contrast manipulation.
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/K980831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980831: Image Post-Processing Techniques.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980831
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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