510(k) · Cleared
ClearedNeonate Array Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lmt Medical Systems GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 18, 2010 as substantially equivalent to K023929 (Advanced Imaging Research, Inc., 2003) after a 492-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Aug 18, 2010
- Review
- 492 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934396 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934396 Quadrature Lower Extremity CoilMedical Advances, Inc. · 1993
- 1 generation backK023929 Magnetic Resonance Diagnostic DeviceAdvanced Imaging Research, Inc. · 2003
- This deviceK091047 Neonate Array CoilsLmt Medical Systems GmbH · 2010
- Descendant · cites it directly · 0 of its ownK171515 NHAC 16Lmt Medical Systems GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K171515NHAC 16Lmt Medical Systems GmbH · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934396 | Quadrature Lower Extremity Coil | Medical Advances, Inc. | 1993 | — |
| −1 | K023929 | Magnetic Resonance Diagnostic Device | Advanced Imaging Research, Inc. | 2003 | — |
| 0 (this device) | K091047 | Neonate Array Coils | Lmt Medical Systems GmbH | 2010 | — |
| +1 | K171515 | NHAC 16 | Lmt Medical Systems GmbH | 2017 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K023929 | Magnetic Resonance Diagnostic DeviceSummary page 1…Legally marketed devices RIF Coils, Advanced Imaging Research, Inc. (K023929) Reason for 51Q(k): New device (Traditional) LMT Med… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171515 | NHAC 16 | 2017 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171515 (Lmt Medical Systems GmbH, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023929.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Used in a MR Scanner or used in the LMVT nomag IC incubator and a MR Scanner, the Neonate Array Coils (receive only) are indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head (Neonate Head Array Coil) and spine, torso (Neonate Body Array Coil). When interpreted by a trained physician, these images provide information that can be useful in the determination of a…
Read the full statement (129 words)
Used in a MR Scanner or used in the LMVT nomag IC incubator and a MR Scanner, the Neonate Array Coils (receive only) are indicated for use as a diagnostic imaging device to provide transversal, sagittal, coronal and oblique images of the internal structures of the head (Neonate Head Array Coil) and spine, torso (Neonate Body Array Coil). When interpreted by a trained physician, these images provide information that can be useful in the determination of a diagnosis. The excited nucleus is 1H (Proton). The signal received by the coils is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift). The Neonate Array coils are compatible to Siemens and Philips MRTs with 1.5T or 3.0T.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091047: Neonate Array Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091047
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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