510(k) Report

510(k) · Cleared

Cleared

Model #100GE1500 Lower Extrem Quad Detect Array Coil

K933659510(k) TraditionalCleared Nov 22, 1993118-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

Medic, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Nov 22, 1993 after a 118-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.

Decided
Nov 22, 1993
Review
118 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2014: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2024: 2 descendants cleared1990200020102020
  1. This deviceK933659 Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc. · 1993
  2. Descendant · cites it directly · 10 of its ownK022395 1.5T Scanmed PV ArrayMedic, Inc. · 2002
  3. Descendant · 2 generations on · 9 of its ownK140606 1.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014
  4. Descendant · 3 generations on · 7 of its ownK142755 Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014
  5. Descendant · 4 generations on · 6 of its ownK173446 Contour 24Quality Electrodynamics, LLC · 2017
  6. Descendant · 5 generations on · 3 of its ownK183111 Contour 24Quality Electrodynamics, LLC · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002: 12014: 32017: 12018: 12020: 22023: 12024: 2
2002high 3 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · See all
  • K0223951.5T Scanmed PV ArrayMedic, Inc. · 2002 · cites it directly10descendants
  • K1406061.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014 · 2 generations on9descendants
  • K142755Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014 · 3 generations on7descendants
  • K173446Contour 24Quality Electrodynamics, LLC · 2017 · 4 generations on6descendants
  • K183111Contour 24Quality Electrodynamics, LLC · 2018 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933659Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc.1993—
+1K0223951.5T Scanmed PV ArrayMedic, Inc.2002—
+2K1406061.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC2014—
+3K142755Siemens 3.0 Blanket Array CoilResonance Innovations, LLC2014—
+4K173446Contour 24Quality Electrodynamics, LLC2017—
+5K183111Contour 24Quality Electrodynamics, LLC2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201430
201710
201810
202020
202310
202420
FIG. 1 — Lineage of K933659, 1993–2024Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K0223951.5T Scanmed PV ArrayMedic, Inc.200210

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, K022395 (Medic, Inc., 2002) has gone furthest, with 10 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 Medic, Inc.

12 FDA decisions under this applicant name. See the company

  • K0223951.5T Scanmed PV ArrayMedic, Inc. · 2002
  • K951649Model #801GE1500 Pediatric Array CoilMedic, Inc. · 1995
  • K942874Model #300TO3500 Shoulder CoilMedic, Inc. · 1994
  • K942873Model #700TO3500 Neck/Abdominal CoilMedic, Inc. · 1994
  • K942875Model #900TO3500 Head/Neck CoilMedic, Inc. · 1994

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/K933659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933659: Model #100GE1500 Lower Extrem Quad Detect Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933659

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