510(k) · Cleared
ClearedPediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 11, 2014 as substantially equivalent to K113365 (Advanced Imaging Research Dba Sree Medical Systems, 2012) after an 84-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jul 11, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001870 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK001870 Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc. · 2000
- 4 generations backK032618 3.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc. · 2003
- 3 generations backK052916 Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 2005 · Recalled
- 2 generations backK093348 3.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009
- 1 generation backK113365 Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012
- This deviceK140998 Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014
- Descendant · cites it directly · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001870 | Millennium 9000 Phased Array Neurovascular Coil | Usa Instruments, Inc. | 2000 | — |
| −4 | K032618 | 3.0T 8 Channel Neurovascular (NV) Array Coil | Usa Instruments, Inc. | 2003 | — |
| −3 | K052916 | Usa Instruments 3.0T Brain/Spine Array | Usa Instruments, Inc. | 2005 | 1 |
| −2 | K093348 | 3.0T 16 Channel Head Neck Spine Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2009 | — |
| −1 | K113365 | Infant Array | Advanced Imaging Research Dba Sree Medical Systems | 2012 | — |
| 0 (this device) | K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil | Quality Electrodynamics, LLC | 2014 | — |
| +1 | K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil… | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K113365 | Infant ArraySummary page 1…Coil, magnetic resonance, specialty 6. Classification 21 CFR 892.1000 7. Equivalent Device Infant Array, Advanced Imaging Research, Inc., K1 13365 8. Device Description This filing describes local RF coils intended to be used with the MAGNETOM Aera and… | 2012 |
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 |
|---|---|---|---|
| K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4… | 2019 | 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 14 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K183186 (Shanghai United Imaging Healthcare Co., Ltd., 2019) has gone furthest, with 0 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 Pediatric 16 is intended for use with the Siemens I.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140998: Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140998
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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