510(k) · Cleared
ClearedCordless Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution, Inc. USA · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 25, 2005 as substantially equivalent to K003192 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Mar 25, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970852 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK970852 Magnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK041111 Magnetom C! MR SystemSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK043030 Magnetom C! MR SystemSiemens Medical Solutions · 2004
- This deviceK050476 Cordless CoilSiemens Medical Solution, Inc. USA · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970852 | Magnetom Project 024 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −2 | K041111 | Magnetom C! MR System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K043030 | Magnetom C! MR System | Siemens Medical Solutions | 2004 | — |
| 0 (this device) | K050476 | Cordless Coil | Siemens Medical Solution, Inc. USA | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K003192 | Magnetic ConcertoSummary page 2…ct of 1990, the cordless coil for MAGNETOM Concerto and MAGNETOM C! is substantially equivalent to: Coils used with Siemens Medical SolutionsK03122//20 K003192 12/21/2000 MAGNETOM Concerto _____ ________ Coils… | 2000 |
| * | K043030 | Magnetom C! MR SystemSummary page 2…12/21/2000 MAGNETOM Concerto _____ ________ Coils used with Siemens Medical SolutionsK430 K043030 12/09/2004 MAGNETOM C! _______ _____ T… | 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 8 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 1 of the 4 ancestors has a recall of any class.
- 5 other devices also cite its predicate K003192.
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 Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be…
Read the full statement (116 words)
The Cordless coil is a receive type surface coil.
When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (TI), and the spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050476: Cordless Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050476
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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