510(k) · Cleared
Cleared31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual Turned Surface Coil 3T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rapid Biomedical GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 22, 2010 as substantially equivalent to K020991 (Siemens Medical Solutions USA, Inc., 2002) after a 125-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Dec 22, 2010
- Review
- 125 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970852 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK102348 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil…Rapid Biomedical GmbH · 2010
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) | K102348 | 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C… | Rapid Biomedical GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K020991 | Syngo MR 2002BSummary page 3…Device Name FDA Clearance Number IFDA Clearance Date Siemens Medical Solutions 31P/IH heart/liver coil included in syngo MR K020991 Jun 13", 2002 20028B____________________ Summary of Technological Characteristi… | 2002 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 6 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K020991.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on I H (proton) and either 3 1P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or, spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102348: 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual Turned Surface Coil 3T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102348
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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