510(k) · Cleared
Cleared1.5T Procure Array Coil, 3.0T Procure Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resonance Innovations, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on May 12, 2014 as substantially equivalent to K022395 (Medic, Inc., 2002) after a 63-day review. Its family tree reaches back 2 generations to 1993. 9 later devices descend from it.
- Decided
- May 12, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933659 (1993). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK933659 Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc. · 1993
- 1 generation backK022395 1.5T Scanmed PV ArrayMedic, Inc. · 2002
- This deviceK140606 1.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014
- Descendant · cites it directly · 7 of its ownK142755 Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK173446 Contour 24Quality Electrodynamics, LLC · 2017
- Descendant · 3 generations on · 3 of its ownK183111 Contour 24Quality Electrodynamics, LLC · 2018
- Descendant · 4 generations on · 2 of its ownK223429 Contour KneeQuality Electrodynamics, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK193140 Flex Body SPEEDERQuality Electrodynamics, LLC · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142755Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014 · cites it directly7descendants
- K173446Contour 24Quality Electrodynamics, LLC · 2017 · 2 generations on6descendants
- K183111Contour 24Quality Electrodynamics, LLC · 2018 · 3 generations on3descendants
- K223429Contour KneeQuality Electrodynamics, LLC · 2023 · 4 generations on2descendants
- K193140Flex Body SPEEDERQuality Electrodynamics, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933659 | Model #100GE1500 Lower Extrem Quad Detect Array Coil | Medic, Inc. | 1993 | — |
| −1 | K022395 | 1.5T Scanmed PV Array | Medic, Inc. | 2002 | — |
| 0 (this device) | K140606 | 1.5T Procure Array Coil, 3.0T Procure Array Coil | Resonance Innovations, LLC | 2014 | — |
| +1 | K142755 | Siemens 3.0 Blanket Array Coil | Resonance Innovations, LLC | 2014 | — |
| +2 | K173446 | Contour 24 | Quality Electrodynamics, LLC | 2017 | — |
| +3 | K183111 | Contour 24 | Quality Electrodynamics, LLC | 2018 | — |
| +4 | K223429 | Contour Knee | Quality Electrodynamics, LLC | 2023 | — |
| +3 | K193140 | Flex Body SPEEDER | Quality Electrodynamics, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
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 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022395 | 1.5T Scanmed PV ArraySummary page 1…Coil, Magnetic Resonance, Specialty Classification Code: MOS Predicate Device: 1.5T ScanMed'DPV Array, K022395 Description of the Device The PROCURETM Coil Family interfaces with a 1.5T or 3.OT 8-channel GE MR] scanner and provide… | 2002 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142755 (Resonance Innovations, LLC, 2014) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The coil is indicated for use by the order of a physician to be used as an accessory to a General Electric 1.5T or 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140606: 1.5T Procure Array Coil, 3.0T Procure Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140606
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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