510(k) · Cleared
ClearedFlex and Loop Coil Set 1.5 T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 26, 2007 as substantially equivalent to K063373 (Siemens AG, 2006) after a 19-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Mar 26, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971684 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK050200 Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 1 generation backK063373 Flex Loop Coil Set 3TSiemens AG · 2006
- This deviceK070629 Flex and Loop Coil Set 1.5 TSiemens Medical Solutions · 2007
- Descendant · cites it directly · 0 of its ownK110373 Temporomanibular Coil 15Esaote, S.p.A. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110373Temporomanibular Coil 15Esaote, S.p.A. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −3 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −2 | K050200 | Magnetom Trio a Tim System | Siemens Medical Solutions USA, Inc. | 2005 | 3 |
| −1 | K063373 | Flex Loop Coil Set 3T | Siemens AG | 2006 | — |
| 0 (this device) | K070629 | Flex and Loop Coil Set 1.5 T | Siemens Medical Solutions | 2007 | — |
| +1 | 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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K063373 | Flex Loop Coil Set 3TSummary page 4…scribed in the following submission: Device Name FDA Clearance Number FDA ClearanceDate Flex Loop Coil Set K063373 Nov 17, 2006 3T Siemens 510(k) Premarket Notification February 13, 2007… | 2006 |
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 |
|---|---|---|---|
| K110373 | Temporomanibular Coil 15 | 2011 | 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 10 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K110373 (Esaote, S.p.A., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K063373.
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 use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and 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 Avanto, Espree and Symphony a Tim…
Read the full statement (146 words)
The intended use of the Flex and Loop Coil Set 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body.
Used in the MAGNETOM Avanto, Espree and Symphony a Tim System, the Flex and 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 Avanto, Espree and Symphony a Tim System with the Flex and Loop Coils 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, Espree and Symphony a Tim System is not affected in any way by the use of the new Flex and Loop Coil Set 1.5T.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070629: Flex and Loop Coil Set 1.5 T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070629
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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