510(k) · Cleared
ClearedModel 473SI-64E Quadrature Lower Extremity Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Igc-Medical Advances, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 20, 2000 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 20, 2000
- Review
- 55 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK001312 Model 473SI-64E Quadrature Lower Extremity CoilIgc-Medical Advances, Inc. · 2000
- Descendant · cites it directly · 4 of its ownK023929 Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK091047 Neonate Array CoilsLmt Medical Systems GmbH · 2010
- Descendant · 3 generations on · 0 of its ownK171515 NHAC 16Lmt Medical Systems GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK083541 Neonate Head and Body CoilsAdvanced Imaging Research, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK061281 Insight Head CoilInsight Neuroimaging Systems, LLC · 2006
Most influential descendants
Showing 5 of 5 · See all- K023929Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 2003 · cites it directly4descendants
- K091047Neonate Array CoilsLmt Medical Systems GmbH · 2010 · 2 generations on1descendant
- K171515NHAC 16Lmt Medical Systems GmbH · 2017 · 3 generations on0descendants
- K083541Neonate Head and Body CoilsAdvanced Imaging Research, Inc. · 2009 · 2 generations on0descendants
- K061281Insight Head CoilInsight Neuroimaging Systems, LLC · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001312 | Model 473SI-64E Quadrature Lower Extremity Coil | Igc-Medical Advances, Inc. | 2000 | — |
| +1 | K023929 | Magnetic Resonance Diagnostic Device | Advanced Imaging Research, Inc. | 2003 | — |
| +2 | K091047 | Neonate Array Coils | Lmt Medical Systems GmbH | 2010 | — |
| +3 | K171515 | NHAC 16 | Lmt Medical Systems GmbH | 2017 | — |
| +2 | K083541 | Neonate Head and Body Coils | Advanced Imaging Research, Inc. | 2009 | — |
| +2 | K061281 | Insight Head Coil | Insight Neuroimaging Systems, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023929 | Magnetic Resonance Diagnostic Device | 2003 | 4 |
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, K023929 (Advanced Imaging Research, Inc., 2003) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K001312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001312: Model 473SI-64E Quadrature Lower Extremity Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001312
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026