510(k) Report

510(k) · Cleared

Recalled · 2008

1.5T Edge and 1.0T Vista Systems

K931544510(k) TraditionalCleared Nov 22, 1993238-day reviewClass II21 CFR 892.1000Recalls 2

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 Nov 22, 1993 after a 238-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it. It has been recalled 2 times.

Decided
Nov 22, 1993
Review
238 days
Class
Class II
Product code
LNH
Recalls
2
Predicates
0

24 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1996: 2 descendants cleared1999: 4 descendants cleared1998: 4 descendants cleared2005: 2 descendants cleared2002: 2 descendants cleared2003: 2 descendants cleared2009: 2 descendants cleared2007: 1 descendant cleared2021: 1 descendant cleared2014: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993
  2. Descendant · cites it directly · 18 of its ownK954646 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

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

1996: 21997: 21998: 41999: 42002: 22003: 22005: 22007: 12008: 12009: 22014: 12021: 1
1996high 4 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 24 · 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 · 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9315441.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc.1993—
+1K954646Epi-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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199720
199840
199940
200220
200320
200520
200710
200810
200920
201410
202110
FIG. 1 — Lineage of K931544, 1993–2021Source: 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), 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
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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? (24)

See all 24

4 later devices cite 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
K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.199715
K961637Picker MR Workstations (Vistar,Montage and Oncall)Philips Medical Systems (Cleveland), Inc.19963
K992892Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC19990

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 19, 2008Not classifiedZ-2429-2010OtherWater may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.
Sep 19, 2008Not classifiedZ-2430-2010OtherWater may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.

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—

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Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K931544 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931544: 1.5T Edge and 1.0T Vista Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931544

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