510(k) · Cleared
Cleared13C/1H Occipital Headcoil for Magnetom Allegra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 12, 2004 as substantially equivalent to K962627 (Siemens Medical Solutions USA, Inc., 1997) and 1 other predicate after a 43-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Nov 12, 2004
- Review
- 43 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970852 (1997). 8 ancestors in all, the oldest K962627 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970852 Magnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK020991 Syngo MR 2002BSiemens Medical Solutions USA, Inc. · 2002 · Recalled
- This deviceK042718 13C/1H Occipital Headcoil for Magnetom AllegraSiemens Medi Cal Solutions, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK080820 Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970852 | Magnetom Project 024 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −1 | K020991 | Syngo MR 2002B | Siemens Medical Solutions USA, Inc. | 2002 | 2 |
| 0 (this device) | K042718 | 13C/1H Occipital Headcoil for Magnetom Allegra | Siemens Medi Cal Solutions, Inc. | 2004 | — |
| +1 | K080820 | Tem 3002G- HN Dual Tune Head Coil | Mr Instruments, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K962627 | Clinical Phosphorus Spectroscopy Option/Magnetom Vision SystemSummary page 2…Premaket Notification Clearance Date Siemens Medical Solutions 3 1P/IH heart/liver coil for Clinical Phosphorus K962627 March 04, 1997 Spectroscopy Option MAGNETOM Vision Siemens Medical Solutions… | 1997 |
| * | K020991 | Syngo MR 2002BSummary page 2…sphorus K962627 March 04, 1997 Spectroscopy Option MAGNETOM Vision Siemens Medical Solutions K020991 June 13, 2002 31P/I-1f heart/liver coil included in syngo MR 2002B GE Medical Systems… | 2002 |
| * | — | Signa 1.5T Phosphorus Transmit/Receive Flex Coil Named without a submission number |
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 |
|---|---|---|---|
| K080820 | Tem 3002G- HN Dual Tune Head Coil | 2008 | 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K080820 (Mr Instruments, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K962627.
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 13C/IH occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 13C spectra can be obtained within the same session without changing the coil. The images produced reflect the spatial…
Read the full statement (141 words)
The 13C/IH occipital headcoil for MAGNETOM Allegra is a transmit/receive surface coil type headcoil double resonant on carbon (13C) and proton (1H) frequencies.
Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce 1H images and 1H spectra of the internal structures of the head. In addition, 13C spectra can be obtained within the same session without changing the coil.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules in which the nucleus under investigation is contained to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and resonance frequency of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042718: 13C/1H Occipital Headcoil for Magnetom Allegra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042718
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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