510(k) · Cleared
Cleared1.5T 32-Channel Head Coil and 3T 32-Channel Head Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 31, 2007 as substantially equivalent to K032428 (Siemens Medical Solutions USA, Inc., 2003) and 1 other predicate after a 19-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Oct 31, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971684 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 1 generation backK050200 Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- This deviceK072909 1.5T 32-Channel Head Coil and 3T 32-Channel Head CoilSiemens AG Medical Solutions · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −2 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −1 | K050200 | Magnetom Trio a Tim System | Siemens Medical Solutions USA, Inc. | 2005 | 3 |
| 0 (this device) | K072909 | 1.5T 32-Channel Head Coil and 3T 32-Channel Head Coil | Siemens AG Medical Solutions | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K032428 | Magnetom Avanto MR SystemSummary page 2…A Clearance Date Number Siemens MAGNETOM Avanto 1.5T K032428 Oct 16, 2003 (Head MATRIX coil) Siemens MAGNETOM Trio a Tim System 3T… | 2003 |
| * | K050200 | Magnetom Trio a Tim SystemSummary page 2…K032428 Oct 16, 2003 (Head MATRIX coil) Siemens MAGNETOM Trio a Tim System 3T K050200 Feb 28, 2005 (Head MATRIX coil) J_ I General… | 2005 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 5 ancestors have a recall of any class.
- 10 other devices also cite its predicate K032428.
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 intended uses of the 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human head. Used in the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System, the 1.5 T 32-channel Head Coil and in the 3 T MAGNETOM Trio, a Tim System, the 3T 32-channel Head Coil are indicated for uses as a diagnostic imaging device to produce transversal, sagittal…
Read the full statement (219 words)
The intended uses of the 1.5T 32-channel Head Coil and the 3T 32-channel Head Coil are, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human head.
Used in the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System, the 1.5 T 32-channel Head Coil and in the 3 T MAGNETOM Trio, a Tim System, the 3T 32-channel Head Coil are indicated for uses as a diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the 1.5 T MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony, a Tim System with the 1.5 T 32-channel Head Coil and the images produced by the 3 T MAGNETOM trio a Tim System with the 3T 32-channel Head Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The intended use of the MAGNETOM Avanto, MAGNETOM Espree or MAGNETOM Symphony a Tim System is not affected in any way by the use of the new 1.5T 32-channel Head Coil.
The intended use of the MAGNETOM Trio a Tim System is not affected in any way by the use of the new 3T 32-channel Head Coil.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072909: 1.5T 32-Channel Head Coil and 3T 32-Channel 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/K072909
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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