510(k) · Cleared
Cleared1.5T Scanmed PV Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medic, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 13, 2002 as substantially equivalent to K933659 (Medic, Inc., 1993) after a 21-day review. Its family tree reaches back 1 generation to 1993. 10 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933659 (1993). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK933659 Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc. · 1993
- This deviceK022395 1.5T Scanmed PV ArrayMedic, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK140606 1.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014
- Descendant · 2 generations on · 7 of its ownK142755 Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014
- Descendant · 3 generations on · 6 of its ownK173446 Contour 24Quality Electrodynamics, LLC · 2017
- Descendant · 4 generations on · 3 of its ownK183111 Contour 24Quality Electrodynamics, LLC · 2018
- Descendant · 5 generations on · 2 of its ownK223429 Contour KneeQuality Electrodynamics, LLC · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K1406061.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014 · cites it directly9descendants
- K142755Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014 · 2 generations on7descendants
- K173446Contour 24Quality Electrodynamics, LLC · 2017 · 3 generations on6descendants
- K183111Contour 24Quality Electrodynamics, LLC · 2018 · 4 generations on3descendants
- K223429Contour KneeQuality Electrodynamics, LLC · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933659 | Model #100GE1500 Lower Extrem Quad Detect Array Coil | Medic, Inc. | 1993 | — |
| 0 (this device) | K022395 | 1.5T Scanmed PV Array | Medic, Inc. | 2002 | — |
| +1 | K140606 | 1.5T Procure Array Coil, 3.0T Procure Array Coil | Resonance Innovations, LLC | 2014 | — |
| +2 | K142755 | Siemens 3.0 Blanket Array Coil | Resonance Innovations, LLC | 2014 | — |
| +3 | K173446 | Contour 24 | Quality Electrodynamics, LLC | 2017 | — |
| +4 | K183111 | Contour 24 | Quality Electrodynamics, LLC | 2018 | — |
| +5 | K223429 | Contour Knee | Quality Electrodynamics, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 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 |
|---|---|---|---|
| * | K933659 | Model #100GE1500 Lower Extrem Quad Detect Array CoilSummary page 1…e Tradename: Lower Extremity Quadrature Detection Array Coil Model # 100GE1500 Unmodified Device 5 10(k) No. K9 33659. 4. Device Description: The 1.5T PV Array, Catalog ## 155GE1501, interfaces with the G.E. 1.5 Tesla S… | 1993 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140606 | 1.5T Procure Array Coil, 3.0T Procure Array Coil | 2014 | 9 |
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, K140606 (Resonance Innovations, LLC, 2014) has gone furthest, with 9 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.
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?
Soft tissue and bone imaging of both lower extremities simultaneously as allowed by the MRI system.
Magnetic resonance peripheral angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022395: 1.5T Scanmed PV Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022395
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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