510(k) · Cleared
ClearedInsight Head Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insight Neuroimaging Systems, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 19, 2006 as substantially equivalent to K021330 (Usa Instruments, Inc., 2002) and 2 other predicates after a 42-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jun 19, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002179 (2000). 6 ancestors in all, the oldest K934396 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK002179 Magnetom Allegra SystemSiemens Medical Solutions USA, Inc. · 2000 · Recalled
- 2 generations backK021330 Magnetom Trio Quadrature TX/RX Head CoilUsa Instruments, Inc. · 2002
- 1 generation backK040937 Tem 3000 Head CoilMr Instruments, Inc. · 2004
- This deviceK061281 Insight Head CoilInsight Neuroimaging Systems, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002179 | Magnetom Allegra System | Siemens Medical Solutions USA, Inc. | 2000 | 2 |
| −2 | K021330 | Magnetom Trio Quadrature TX/RX Head Coil | Usa Instruments, Inc. | 2002 | — |
| −1 | K040937 | Tem 3000 Head Coil | Mr Instruments, Inc. | 2004 | — |
| 0 (this device) | K061281 | Insight Head Coil | Insight Neuroimaging Systems, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K021330 | Magnetom Trio Quadrature TX/RX Head CoilSummary page 3…ces listed below: Model: Magnetom Trio Head Coil Manufacturer: USA Instruments 510 (k) Number: K021330 Model: AIR Head Coil Manufacturer: Advanced Imaging Research 51… | 2002 |
| * | K023929 | Magnetic Resonance Diagnostic DeviceSummary page 3…K021330 Model: AIR Head Coil Manufacturer: Advanced Imaging Research 510 (k) Number: K023929 Model: TEM 3000 Head Coil Manufacturer: MR Instrunments Inc. 51… | 2003 |
| * | K040937 | Tem 3000 Head CoilSummary page 3…K023929 Model: TEM 3000 Head Coil Manufacturer: MR Instrunments Inc. 510(k)Number: K040937 All of these head coils are intended for use in conjunction with a magnetic resonance scanner to produce… | 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 6 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K021330.
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?
The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061281: Insight Head Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061281
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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