510(k) · Cleared
ClearedMagnetic Resonance Diagnostic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Imaging Research, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 21, 2003 as substantially equivalent to K934396 (Medical Advances, Inc., 1993) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Feb 21, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934396 (1993). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK934396 Quadrature Lower Extremity CoilMedical Advances, Inc. · 1993
- This deviceK023929 Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK091047 Neonate Array CoilsLmt Medical Systems GmbH · 2010
- Descendant · 2 generations on · 0 of its ownK171515 NHAC 16Lmt Medical Systems GmbH · 2017
- Descendant · cites it directly · 0 of its ownK083541 Neonate Head and Body CoilsAdvanced Imaging Research, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK061281 Insight Head CoilInsight Neuroimaging Systems, LLC · 2006
Most influential descendants
Showing 4 of 4 · See all- K091047Neonate Array CoilsLmt Medical Systems GmbH · 2010 · cites it directly1descendant
- K171515NHAC 16Lmt Medical Systems GmbH · 2017 · 2 generations on0descendants
- K083541Neonate Head and Body CoilsAdvanced Imaging Research, Inc. · 2009 · cites it directly0descendants
- K061281Insight Head CoilInsight Neuroimaging Systems, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934396 | Quadrature Lower Extremity Coil | Medical Advances, Inc. | 1993 | — |
| 0 (this device) | K023929 | Magnetic Resonance Diagnostic Device | Advanced Imaging Research, Inc. | 2003 | — |
| +1 | K091047 | Neonate Array Coils | Lmt Medical Systems GmbH | 2010 | — |
| +2 | K171515 | NHAC 16 | Lmt Medical Systems GmbH | 2017 | — |
| +1 | K083541 | Neonate Head and Body Coils | Advanced Imaging Research, Inc. | 2009 | — |
| +1 | K061281 | Insight Head Coil | Insight Neuroimaging Systems, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K934396 | Quadrature Lower Extremity CoilSummary page 1…DEVICE(S): GE Quadrature Head Coils IGC-Medical Advances Inc. Quadrature Knee/Foot Coils K934396 approved 11/24/1993 KO0 1312 approved 06/20/2000 3.0 DEVICE DESCRIPTION: 3.1 FUNCTION… | 1993 |
| * | K001312 | Model 473SI-64E Quadrature Lower Extremity Coil | 2000 |
What descends from it? (4)
3 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?
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?
The RF coils when used in conjunction with the MRI systems or RF coils when used with the incubator system and both the incubator and RF coils used in conjunction with the MRI systems provide imaging of the adult head, extremity, neonate head and body. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Anatomical Region: Adult Head, Extremity
Neonate Head, Body (heart, spine, pelvis, extremity)
Nucleus Excited: Proton 1H
Diagnostic Uses: ID, 2D, 3D TI, T2 Weighting
Proton Density
Chemical Shift
MR Blood Flow
MR Spectroscopy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023929: Magnetic Resonance Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023929
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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