510(k) · Cleared
ClearedNeocoil 3.0T 6-Channel Carotid Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocoil · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 11, 2007 as substantially equivalent to K012491 (Machnet BV, 2001) and 2 other predicates after a 21-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 11, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001582 (2000). 7 ancestors in all, the oldest K001210 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
- 2 generations backK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · Recalled
- 1 generation backK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005 · Recalled
- This deviceK070778 Neocoil 3.0T 6-Channel Carotid Array CoilNeocoil · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001582 | Liberty 9000 Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2000 | — |
| −2 | K041695 | Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2004 | 5 |
| −1 | K052585 | 3T HD Breast Array | Usa Instruments, Inc. | 2005 | 5 |
| 0 (this device) | K070778 | Neocoil 3.0T 6-Channel Carotid Array Coil | Neocoil | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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? (3)
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 2…ches. These passive switched detune the antennas further during RF transmit. Predicate Devices: Machnet Carotids Coil Array Assembly (K012491) USAI 3T HD Breast Array (K052585) USAI Millennium III 3T-8-Channel Neurova… | 2001 |
| * | K052585 | 3T HD Breast ArraySummary page 2…during RF transmit. Predicate Devices: Machnet Carotids Coil Array Assembly (K012491) USAI 3T HD Breast Array (K052585) USAI Millennium III 3T-8-Channel Neurovascular Coil (K042342) Comparison to Predicate: It is our o… | 2005 |
| * | K042342 | Millennium Iii 3T-8-Channel Neurovascular CoilSummary page 2…oil Array Assembly (K012491) USAI 3T HD Breast Array (K052585) USAI Millennium III 3T-8-Channel Neurovascular Coil (K042342) Comparison to Predicate: It is our opinion that the NeoCoil 3.OT 6-Channel Carotid Array Coil in this… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 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. 2007, 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 NeoCoil 3.QT 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.OT 6-Channel Carotid Array Coil is…
Read the full statement (185 words)
The NeoCoil 3.QT 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.OT 6-Channel Carotid Array Coil is designed for use with the HD series (3.0Tesla) MRI scanners manufactured by General Electric Healthcare (GEHC). Anatomic Regions: Head and neck vasculature. Nuclei Excited: Hydrogen.
The indications for use are the same as for standard imaging:
The GE scanner 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 T1, 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/K070778 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070778: Neocoil 3.0T 6-Channel Carotid Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070778
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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