510(k) · Cleared
ClearedNoras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noras Mri Products GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 24, 2009 as substantially equivalent to K060758 (Siemens Medical Solutions USA, Inc., 2006) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Jun 24, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013159 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013159 HRH-63-8 Head Array CoilMri Devices Corp. · 2001
- 1 generation backK060758 OR Head Coil 1.5 TSiemens Medical Solutions USA, Inc. · 2006
- This deviceK091546 Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH · 2009
- Descendant · cites it directly · 0 of its ownK190668 Encompass 15 Channel Head Coil, 3TQfix · 2019
Most influential descendants
Showing 1 of 1 · See all- K190668Encompass 15 Channel Head Coil, 3TQfix · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013159 | HRH-63-8 Head Array Coil | Mri Devices Corp. | 2001 | — |
| −1 | K060758 | OR Head Coil 1.5 T | Siemens Medical Solutions USA, Inc. | 2006 | — |
| 0 (this device) | K091546 | Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230 | Noras Mri Products GmbH | 2009 | — |
| +1 | K190668 | Encompass 15 Channel Head Coil, 3T | Qfix | 2019 | — |
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? (2)
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 |
|---|---|---|---|
| * | K060758 | OR Head Coil 1.5 TSummary page 3…roduct Comparable Manufacturer Number Code Properties Noras OR Head Coil 1,5T K060758 March 21, 2006 90MOS Proton imaging MRI Devices Corporation (now K013159 October 1… | 2006 |
| * | K013159 | HRH-63-8 Head Array CoilSummary page 3…Properties Noras OR Head Coil 1,5T K060758 March 21, 2006 90MOS Proton imaging MRI Devices Corporation (now K013159 October 16, 2001 90MOS High Resolution known as Invivo Corporation)… | 2001 |
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 |
|---|---|---|---|
| K190668 | Encompass 15 Channel Head Coil, 3T | 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?
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 intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091546: Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091546
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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