510(k) · Cleared
ClearedCarotid Coil 5000004901
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Chenguang Medical Technologies Co, Ltd. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 9, 2009 as substantially equivalent to K012491 (Machnet BV, 2001) after a 14-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001210 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001210 HI-Res 9000 Phased Array Carotid CoilUsa Instruments, Inc. · 2000
- 1 generation backK012491 Machnet Carotids Coil Array AssemblyMachnet BV · 2001
- This deviceK092962 Carotid Coil 5000004901Shanghai Chenguang Medical Technologies Co, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK112002 Carotid CoilShanghai Chenguang Medical Technologies Co, Ltd. · 2011
- Descendant · 2 generations on · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001210 | HI-Res 9000 Phased Array Carotid Coil | Usa Instruments, Inc. | 2000 | — |
| −1 | K012491 | Machnet Carotids Coil Array Assembly | Machnet BV | 2001 | — |
| 0 (this device) | K092962 | Carotid Coil 5000004901 | Shanghai Chenguang Medical Technologies Co, Ltd. | 2009 | — |
| +1 | K112002 | Carotid Coil | Shanghai Chenguang Medical Technologies Co, Ltd. | 2011 | — |
| +2 | K183186 | Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil… | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012491 | Machnet Carotids Coil Array AssemblySummary page 1…cate Devices (Legally Marketed Devices) The predicate device for the Carotid Coil is the Machnet Carotids Coil Array Assembly from Machnet B.V., with the 510k number of K012491. Device Description The Carotid Coil is an 8-channel phased array, receive-only coil, used for obtaining diagnostic images of… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112002 | Carotid Coil | 2011 | 1 |
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 9 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112002 (Shanghai Chenguang Medical Technologies Co, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K012491.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Carotid Coil is a receive-only coil, used for obtaining diagnostic images of carotid in magnetic resonance imaging systems. These images when interpreted by a trained physician, yielding information that may assist in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092962 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092962: Carotid Coil 5000004901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092962
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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