510(k) · Cleared
ClearedMachnet Carotids Coil Array Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Machnet BV · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 24, 2001 as substantially equivalent to K001210 (Usa Instruments, Inc., 2000) after an 82-day review. Its family tree reaches back 1 generation to 2000. 19 of the 231 devices in its family, counting itself, have a Class I recall. 229 later devices descend from it.
- Decided
- Oct 24, 2001
- Review
- 82 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001210 (2000). 229 later devices descend from it, 4 citing it directly. 19 of the 231 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK001210 HI-Res 9000 Phased Array Carotid CoilUsa Instruments, Inc. · 2000
- This deviceK012491 Machnet Carotids Coil Array AssemblyMachnet BV · 2001
- Descendant · cites it directly · 222 of its ownK083166 Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 221 of its ownK103275 Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSiemens Medical Solutions USA, Inc. · 2011
- Descendant · 3 generations on · 220 of its ownK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 215 of its ownK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- Descendant · 5 generations on · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
Showing 5 of 229 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 229 · See all- K083166Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2009 · cites it directly222descendants
- K103275Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSiemens Medical Solutions USA, Inc. · 2011 · 2 generations on221descendants
- K111242Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · 3 generations on220descendants
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 4 generations on215descendants
- K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · 5 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001210 | HI-Res 9000 Phased Array Carotid Coil | Usa Instruments, Inc. | 2000 | — |
| 0 (this device) | K012491 | Machnet Carotids Coil Array Assembly | Machnet BV | 2001 | — |
| +1 | K083166 | Specialty Coils for the Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K103275 | Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR Systems | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +3 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| +4 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| +5 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 1 |
| 2013 | 12 | 2 |
| 2014 | 8 | 0 |
| 2015 | 7 | 1 |
| 2016 | 5 | 1 |
| 2017 | 15 | 1 |
| 2018 | 18 | 2 |
| 2019 | 20 | 1 |
| 2020 | 22 | 3 |
| 2021 | 9 | 1 |
| 2022 | 22 | 2 |
| 2023 | 25 | 3 |
| 2024 | 18 | 0 |
| 2025 | 20 | 1 |
| 2026 | 19 | 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.
19 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K001210 | HI-Res 9000 Phased Array Carotid CoilSummary page 1…Assembly 2. Equivalent legally marketed device: This device is similar in design and identical in function to the USA Instruments Hi-Res 9000 Phased Array Carotid Coil K001210. 3. Indications for Use (intended use): To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images… | 2000 |
What descends from it? (229)
See all 2294 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (19 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
- K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 9 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 19 shown.
Nearest 5 of 19; all are on the web page.
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?
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician. The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis. Anatomic Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging; The GE…
Read the full statement (149 words)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of Carotid structures that can be interpreted by a trained physician.
The Machnet Carotids Coil is designed to provide coverage of the carotid arteries and associated vasculature from the aortic arch through the Circle-of-Willis.
Anatomic Regions: Head and Neck Vasculature. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging;
The GE Signa system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time TI, spin-spin relaxation time T2) and (3) display the vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012491 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012491: Machnet Carotids Coil Array Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012491
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026