510(k) Report

510(k) · Cleared

Cleared

Quadrature and Phased Array Flexible Body Coils

K962117510(k) TraditionalCleared Aug 27, 199688-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 Aug 27, 1996 as substantially equivalent to K954190 (Medical Advances, Inc., 1995) after an 88-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided
Aug 27, 1996
Review
88 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K954190 (1995). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2003: 1 descendant clearedK954190 · Model 580GE-64 Quadrature Abdominal Flex Coil · Medical Advances, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K954190 · Model 580GE-64 Quadrature Abdominal Flex Coil · Medical Advances, Inc. · 19950
  1. Root · 1 generation backK954190 Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc. · 1995
  2. This deviceK962117 Quadrature and Phased Array Flexible Body CoilsPhilips Medical Systems (Cleveland), Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK984588 Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc. · 1999
  4. Descendant · 2 generations on · 0 of its ownK031095 Sense Body CoilPhilips Medical Systems (Cleveland), Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K984588Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc. · 1999 · cites it directly1descendant
  • K031095Sense Body CoilPhilips Medical Systems (Cleveland), Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954190Model 580GE-64 Quadrature Abdominal Flex CoilMedical Advances, Inc.1995—
0 (this device)K962117Quadrature and Phased Array Flexible Body CoilsPhilips Medical Systems (Cleveland), Inc.1996—
+1K984588Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc.1999—
+2K031095Sense Body CoilPhilips Medical Systems (Cleveland), Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
FIG. 1 — Lineage of K962117, 1995–2003Source: 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
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What was it cleared against? (1)

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
*K954190Model 580GE-64 Quadrature Abdominal Flex Coil
Summary page 2
…ty and Effectiveness The Picker Quadrature and Phased Array Flexible Body Coils are substantially equivalent to the MAI Quadrature and Phased Array Abdominal Flex Coils (K954190) in safety and effectiveness. The following chart has been compiled to demonstrate the Flexible Body Coils substantial equivalen…
Medical Advances, Inc.1995—

Also cleared against K954190: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K984588Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc.19991

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?

  • Its one ancestor has no recall.
  • Of its descendants, K984588 (Philips Medical Systems (Cleveland), Inc., 1999) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K954190.

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 Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system. The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body.…

Read the full statement (133 words)

The Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system.

The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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.

The Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures

Nuclei Excited: Hydrogen

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 K954190

1 other device cites the same predicate.

  • K0938421.5T and 3.0T General Purpose Flex CoilsInvivo Corporation · 2010

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https://510kreport.com/device/K962117 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962117: Quadrature and Phased Array Flexible Body Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962117

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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