510(k) Report

510(k) · Cleared

Cleared

Echo Planar Imaging I

K945828510(k) TraditionalCleared Apr 12, 1995134-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 Apr 12, 1995 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Apr 12, 1995
Review
134 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

19 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 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 cleared1995200020052010201520202025
  1. This deviceK945828 Echo Planar Imaging IPhilips Medical Systems (Cleveland), Inc. · 1995
  2. Descendant · cites it directly · 18 of its ownK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
  3. Descendant · 2 generations on · 15 of its ownK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
  4. Descendant · 3 generations on · 11 of its ownK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
  5. Descendant · 4 generations on · 5 of its ownK013858 Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · Recalled
  6. Descendant · 4 generations on · 4 of its ownK024042 Panorama EnhancementsPhilips Medical Systems, Inc. · 2003

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1996: 11997: 21998: 41999: 22002: 22003: 22005: 22007: 12008: 12009: 12014: 1
1996high 4 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 19 · See all
  • K954646Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996 · cites it directly18descendants
  • K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · 2 generations on15descendants
  • K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998 · 3 generations on11descendants
  • K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · 4 generations on5descendants
  • K024042Panorama EnhancementsPhilips Medical Systems, Inc. · 2003 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945828Echo Planar Imaging IPhilips Medical Systems (Cleveland), Inc.1995—
+1K954646Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc.1996—
+2K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.19974
+3K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.1998—
+4K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc.20022
+4K024042Panorama EnhancementsPhilips Medical Systems, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
199840
199920
200220
200320
200520
200710
200810
200910
201410
FIG. 1 — Lineage of K945828, 1995–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K954646Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc.199618

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, K954646 (Philips Medical Systems (Cleveland), Inc., 1996) has gone furthest, with 18 descendants of its own.

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—

More from Philips Medical Systems (Cleveland)…

209 FDA decisions under this applicant name. See the company

  • K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 201714 recalls
  • 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

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K945828 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945828: Echo Planar Imaging I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945828

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026