510(k) Report

510(k) · Cleared

Cleared

Contour 24

K173446510(k) TraditionalCleared Nov 17, 201711-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

Quality Electrodynamics, LLC · MOS Coil, Magnetic Resonance, Specialty

Cleared on Nov 17, 2017 as substantially equivalent to K142755 (Resonance Innovations, LLC, 2014) after an 11-day review. Its family tree reaches back 4 generations to 1993. 6 later devices descend from it.

Decided
Nov 17, 2017
Review
11 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K933659 (1993). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2020: 2 descendants cleared2023: 1 descendant cleared2024: 2 descendants clearedK933659 · Model #100GE1500 Lower Extrem Quad Detect Array Coil · Medic, Inc. · 1993K022395 · 1.5T Scanmed PV Array · Medic, Inc. · 2002K140606 · 1.5T Procure Array Coil, 3.0T Procure Array Coil · Resonance Innovations, LLC · 2014K142755 · Siemens 3.0 Blanket Array Coil · Resonance Innovations, LLC · 20141990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K142755 · Siemens 3.0 Blanket Array Coil · Resonance Innovations, LLC · 2014K140606 · 1.5T Procure Array Coil, 3.0T Procure Array Coil · Resonance Innovations, LLC · 2014K022395 · 1.5T Scanmed PV Array · Medic, Inc. · 2002K933659 · Model #100GE1500 Lower Extrem Quad Detect Array Coil · Medic, Inc. · 19930
  1. Root · 4 generations backK933659 Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc. · 1993
  2. 3 generations backK022395 1.5T Scanmed PV ArrayMedic, Inc. · 2002
  3. 2 generations backK140606 1.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014
  4. 1 generation backK142755 Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014
  5. This deviceK173446 Contour 24Quality Electrodynamics, LLC · 2017
  6. Descendant · cites it directly · 3 of its ownK183111 Contour 24Quality Electrodynamics, LLC · 2018
  7. Descendant · 2 generations on · 2 of its ownK223429 Contour KneeQuality Electrodynamics, LLC · 2023
  8. Descendant · cites it directly · 1 of its ownK193140 Flex Body SPEEDERQuality Electrodynamics, LLC · 2020
  9. Descendant · 3 generations on · 0 of its ownK233652 Contour Hand/Wrist (Q7000232)Quality Electrodynamics · 2024
  10. Descendant · 3 generations on · 0 of its ownK233656 Contour ShoulderQuality Electrodynamics · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12020: 22023: 12024: 2
2018high 2 (2020) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K183111Contour 24Quality Electrodynamics, LLC · 2018 · cites it directly3descendants
  • K223429Contour KneeQuality Electrodynamics, LLC · 2023 · 2 generations on2descendants
  • K193140Flex Body SPEEDERQuality Electrodynamics, LLC · 2020 · cites it directly1descendant
  • K233652Contour Hand/Wrist (Q7000232)Quality Electrodynamics · 2024 · 3 generations on0descendants
  • K233656Contour ShoulderQuality Electrodynamics · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K933659Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc.1993—
−3K0223951.5T Scanmed PV ArrayMedic, Inc.2002—
−2K1406061.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC2014—
−1K142755Siemens 3.0 Blanket Array CoilResonance Innovations, LLC2014—
0 (this device)K173446Contour 24Quality Electrodynamics, LLC2017—
+1K183111Contour 24Quality Electrodynamics, LLC2018—
+2K223429Contour KneeQuality Electrodynamics, LLC2023—
+1K193140Flex Body SPEEDERQuality Electrodynamics, LLC2020—
+3K233652Contour Hand/Wrist (Q7000232)Quality Electrodynamics2024—
+3K233656Contour ShoulderQuality Electrodynamics2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202020
202310
202420
FIG. 1 — Lineage of K173446, 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), 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 MOS? 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 MOS device

  1. #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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? (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
*K142755Siemens 3.0 Blanket Array Coil
Summary page 4
…(21 CFR 892.1000, Product Code MOS, Class II) 8. Predicate Device Siemens 3.0T Blanket Array Coil manufactured by Resonance Innovations LLC., K142755 9. Device Description The Contour 24 is a receive-only, 24-channel phased array coil designed for magnetic re…
Resonance Innovations, LLC2014—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K183111Contour 24Quality Electrodynamics, LLC20183
K193140Flex Body SPEEDERQuality Electrodynamics, LLC20201

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?

  • The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K183111 (Quality Electrodynamics, LLC, 2018) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007: 162008: 192009: 102010: 162011: 252012: 152013: 72014: 122015: 62016: 112017: 92018: 102019: 32020: 52021: 42022: 112023: 102024: 102025: 32026 (partial year): 10
2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007: 19 days median2008: 33 days median2009: 43 days median2010: 78 days median2011: 57 days median2012: 49 days median2013: 87 days median2014: 60 days median2015: 58 days median2016: 42 days median2017: 63 days median2018: 30 days median2019: 178 days median2020: 51 days median2021: 41 days median2022: 79 days median2023: 59 days median2024: 39 days median2025: 59 days median2026 (partial year): 45 days median
2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2008: 22010: 12012: 12015: 22019: 82020: 12024: 13
2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007: 42008: 22009: 52010: 132011: 72012: 122013: 102014: 42015: 52016: 72017: 92018: 72019: 82020: 22021: 32022: 52023: 42024: 82025: 2
2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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
2007161904
2008193322
2009104305
20101678113
2011255707
20121549112
2013787010
2014126004
201565825
2016114207
201796309
2018103007
2019317888
202055112
202144103
2022117905
2023105904
20241039138
202535902
202610450—

What is it indicated for?

The Contour 24 is intended for use with Siemens 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

Indications for use as stated in the FDA summary.

More from Quality Electrodynamics, LLC

21 FDA decisions under this applicant name. See the company

  • K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC · 2025
  • K223429Contour KneeQuality Electrodynamics, LLC · 2023
  • K200477Flex Body SpeederQuality Electrodynamics, LLC · 2020
  • K193140Flex Body SPEEDERQuality Electrodynamics, LLC · 2020
  • K183111Contour 24Quality Electrodynamics, LLC · 2018

Recent decisions in MOS

The MOS category page

  • K262813InkSpace Imaging Small Body Array (SBA12PH15x)Inkspace Imaging, Inc. · 2026
  • K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS…Philips Medical Systems Nederland B.V. · 2026
  • K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS…Philips Medical Systems Nederland B.V. · 2026
  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K173446 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173446: Contour 24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173446

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026