510(k) · Cleared
Cleared16 CH Multipurpose Coil Variety
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noras Rontgen-Und Medizintechnik GmbH · MOS Coil, Magnetic Resonance, Specialty
Cleared on May 8, 2014 as substantially equivalent to K083578 (Noras Mri Products GmbH, 2009) and 1 other predicate after a 97-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- May 8, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971684 (1997). 19 ancestors in all, the oldest K945778 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK050200 Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 2 generations backK063373 Flex Loop Coil Set 3TSiemens AG · 2006
- 1 generation backK083578 Noras CPC Multifunctional CoilNoras Mri Products GmbH · 2009
- This deviceK140252 16 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −4 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −3 | K050200 | Magnetom Trio a Tim System | Siemens Medical Solutions USA, Inc. | 2005 | 3 |
| −2 | K063373 | Flex Loop Coil Set 3T | Siemens AG | 2006 | — |
| −1 | K083578 | Noras CPC Multifunctional Coil | Noras Mri Products GmbH | 2009 | — |
| 0 (this device) | K140252 | 16 CH Multipurpose Coil Variety | Noras Rontgen-Und Medizintechnik GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K083578 | Noras CPC Multifunctional CoilSummary page 4…Name and 51() Cerne Pout Manufacturer Number Date Code 8 Ch Multipurpose Coil K083578 Jan 16 2009 9OMOS (CPC) Intended Use /Indication for Us… | 2009 |
| * | K111673 | 1.5T and 3T 8-Channel Medium General Purpose Flex CoilSummary page 4…Field of View 8-Channel Medium Method of Decoupling General Purpose Flex K1 11673 Dec 23 2011 9OMOS Coil P008_16 Ch Multipurpose Coil VarietySummary_510(k)-revisedJ.docx… | 2011 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 19 ancestors have a recall of any class.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 16 Ch Multipurpose Coil Variety 1.5T and 3T is, in conjunction with a Magnetic Resonance Scanner. body imaging for diagnostic with a MRI system.
It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by atrained physician, these images provide information that can be useful in determining diagnosis.
The outcome of this is diagnostic images of toes, feet, ankle, knee. inger, hand, wrist, elbow, shoulder, carotid ariery. inner ear and other pants of the body with similar structure can be taken.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140252: 16 CH Multipurpose Coil Variety.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140252
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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