510(k) · Cleared
ClearedFlex Loop Coil Set 3T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG · MOS Coil, Magnetic Resonance, Specialty
Cleared on Nov 17, 2006 as substantially equivalent to K971684 (Siemens Medical Solutions USA, Inc., 1997) and 2 other predicates after a 9-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Nov 17, 2006
- Review
- 9 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971684 (1997). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- 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 deviceK063373 Flex Loop Coil Set 3TSiemens AG · 2006
- Descendant · cites it directly · 1 of its ownK083578 Noras CPC Multifunctional CoilNoras Mri Products GmbH · 2009
- Descendant · cites it directly · 1 of its ownK070629 Flex and Loop Coil Set 1.5 TSiemens Medical Solutions · 2007
- Descendant · 2 generations on · 0 of its ownK140252 16 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK110373 Temporomanibular Coil 15Esaote, S.p.A. · 2011
Most influential descendants
Showing 4 of 4 · See all- K083578Noras CPC Multifunctional CoilNoras Mri Products GmbH · 2009 · cites it directly1descendant
- K070629Flex and Loop Coil Set 1.5 TSiemens Medical Solutions · 2007 · cites it directly1descendant
- K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014 · 2 generations on0descendants
- K110373Temporomanibular Coil 15Esaote, S.p.A. · 2011 · 2 generations on0descendants
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) | K063373 | Flex Loop Coil Set 3T | Siemens AG | 2006 | — |
| +1 | K083578 | Noras CPC Multifunctional Coil | Noras Mri Products GmbH | 2009 | — |
| +1 | K070629 | Flex and Loop Coil Set 1.5 T | Siemens Medical Solutions | 2007 | — |
| +2 | K140252 | 16 CH Multipurpose Coil Variety | Noras Rontgen-Und Medizintechnik GmbH | 2014 | — |
| +2 | K110373 | Temporomanibular Coil 15 | Esaote, S.p.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K971684 | Magnetom Project 047 System (Numaris 3.5 Software)Summary page 3…er Date Siemens MAGNETOM 1.5 T S m hon _____Symphony ~~~K971684 Aug. 05 1997 Siemens MAGNETOM 1.5 T Ava-ntoAvanto… | 1997 |
| * | K032428 | Magnetom Avanto MR SystemSummary page 3…~~~K971684 Aug. 05 1997 Siemens MAGNETOM 1.5 T Ava-ntoAvanto ~~~K032428 Oct. 16 2003 Siemens MAGNETOM 3 T Trio, K050200… | 2003 |
| * | K050200 | Magnetom Trio a Tim SystemSummary page 3…Ava-ntoAvanto ~~~K032428 Oct. 16 2003 Siemens MAGNETOM 3 T Trio, K050200 Feb. 28 2005 a Tim System Siemens 510(k) Premarket Notification September 18… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 5 ancestors have a recall of any class.
- Of its descendants, K083578 (Noras Mri Products GmbH, 2009) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K971684.
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 intended use of the Flex Loop Coil Set 3 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in the MAGNETOM 3 T Trio, a Tim System, the Flex Loop Coils are indicated for use 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 MAGNETOM 3 T Trio, a Tim System with the Flex Loop Coils reflect the…
Read the full statement (140 words)
The intended use of the Flex Loop Coil Set 3 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.
Used in the MAGNETOM 3 T Trio, a Tim System, the Flex Loop Coils are indicated for use 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 MAGNETOM 3 T Trio, a Tim System with the Flex Loop Coils reflect the spatial distribution of protons (hydogen 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 3 T Trio, a Tim System is not affected in any way by the use of the new Flex Loop Coil Set 3 T.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063373: Flex Loop Coil Set 3T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063373
Report an extraction error
Are you the manufacturer?
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