510(k) Report

510(k) · Cleared

Cleared

Epi-II System Option W/High Performance Gradients

K954646510(k) TraditionalCleared Jan 18, 1996100-day reviewClass II21 CFR 892.1000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jan 18, 1996 as substantially equivalent to K931544 (Philips Medical Systems (Cleveland), Inc., 1993) and 1 other predicate after a 100-day review. Its family tree reaches back 1 generation to 1993. 18 later devices descend from it.

Decided
Jan 18, 1996
Review
100 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K931544 (1993). 2 ancestors in all. 18 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1997: 2 descendants cleared1998: 4 descendants cleared1999: 2 descendants cleared2005: 2 descendants cleared2002: 2 descendants cleared2003: 2 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2008: 1 descendant clearedK931544 · 1.5T Edge and 1.0T Vista Systems · Philips Medical Systems (Cleveland), Inc. · 1993 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 5 descendants K931544 · 1.5T Edge and 1.0T Vista Systems · Philips Medical Systems (Cleveland), Inc. · 1993 · recalled0+5
  1. Root · 1 generation backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
  2. This deviceK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
  3. Descendant · cites it directly · 15 of its ownK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
  4. Descendant · 2 generations on · 11 of its ownK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
  5. Descendant · 3 generations on · 5 of its ownK013858 Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK024042 Panorama EnhancementsPhilips Medical Systems, Inc. · 2003
  7. Descendant · 3 generations on · 4 of its ownK983342 MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1997: 21998: 41999: 22002: 22003: 22005: 22007: 12008: 12009: 12014: 1
1997high 4 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 18 · See all
  • K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · cites it directly15descendants
  • K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · 2 generations on11descendants
  • K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · 3 generations on5descendants
  • K024042Panorama EnhancementsPhilips Medical Systems, Inc. · 2003 · 3 generations on4descendants
  • K983342MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K9315441.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc.19932
0 (this device)K954646Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc.1996—
+1K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.19974
+2K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.1998—
+3K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc.20022
+3K024042Panorama EnhancementsPhilips Medical Systems, Inc.2003—
+3K983342MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199840
199920
200220
200320
200520
200710
200810
200910
201410
FIG. 1 — Lineage of K954646, 1993–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K9315441.5T Edge and 1.0T Vista Systems
Summary page 4
…information that can be useful in the determination of a diagnosis. b. Effectiveness Compared to the standard EDGE system using the EPI-1 software option (see 510(k)s K931544 and K945828), the EPI-II System Option has a gradient system which is able to produce higher gradient operational levels and prov…
Philips Medical Systems (Cleveland), Inc.19932
*K945828Echo Planar Imaging I
Summary page 4
…that can be useful in the determination of a diagnosis. b. Effectiveness Compared to the standard EDGE system using the EPI-1 software option (see 510(k)s K931544 and K945828), the EPI-II System Option has a gradient system which is able to produce higher gradient operational levels and provide faster s…
Philips Medical Systems (Cleveland), Inc.1995—

Also cleared against K931544: 3 other devices →

What descends from it? (18)

See all 18

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.199715
K974530Duffusion-Weighted MR Imaging PackagePhilips Medical Systems (Cleveland), Inc.19981

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K964626 (Philips Medical Systems (Cleveland), Inc., 1997) has gone furthest, with 15 descendants of its own.
  • 3 other devices also cite its predicate K931544.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

The Picker International EDGE system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K931544

3 other devices cite the same predicate.

  • K992892Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999
  • K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 19974 recalls
  • K961637Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc. · 1996

More from Philips Medical Systems (Cleveland)…

209 FDA decisions under this applicant name. See the company

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  • K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 20173 recalls
  • K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc. · 20176 recalls
  • K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 20172 recalls
  • K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 20173 recalls

Recent decisions in LNH

The LNH category page

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  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
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https://510kreport.com/device/K954646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954646: Epi-II System Option W/High Performance Gradients.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954646

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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