510(k) · Cleared
Cleared14-Channel Extremity Coil for Magnetom Essenza
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 27, 2010 as substantially equivalent to K082636 (Quality Electrodynamics, 2008) after a 220-day review. Its family tree reaches back 5 generations to 1989. 12 later devices descend from it.
- Decided
- Aug 27, 2010
- Review
- 220 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K893619 (1989). 16 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 4 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- 3 generations backK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
- 2 generations backK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
- 1 generation backK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
- This deviceK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013
- Descendant · 2 generations on · 9 of its ownK152283 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK173600 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK163211 MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 4 generations on · 6 of its ownK183221 MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc. · 2019 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · cites it directly11descendants
- K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015 · 2 generations on9descendants
- K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017 · 3 generations on7descendants
- K163211MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc. · 2017 · 3 generations on7descendants
- K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc. · 2019 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −4 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −3 | K971246 | Leo 7000 Quadrature Knee Coil | Usa Instruments, Inc. | 1997 | — |
| −2 | K023982 | Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil | Usa Instruments, Inc. | 2003 | — |
| −1 | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T | Quality Electrodynamics | 2008 | 8 |
| 0 (this device) | K100141 | 14-Channel Extremity Coil for Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +1 | K130262 | Magnetom Essenza with Syngo MR D14 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +2 | K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +3 | K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +3 | K163211 | MAGNETOM Sempra with syngo MR E11S | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +4 | K183221 | MAGNETOM Amira, MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TSummary page 2…Predicate evice NameNumber Date TxRx l5Ch Knee Coil 1.5T K4082636 Sep. 25, 2008 (QED) General Safety and Effectiveness Concerns: The following are the safety… | 2008 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130262 | Magnetom Essenza with Syngo MR D14 | 2013 | 11 |
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 21 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K130262 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K082636.
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 intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist. Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function…
Read the full statement (140 words)
The intended use of the new 14-Channel Extremity Coil is, in conjunction with THE 1.5T MAGNETOM ESSENZA Magnetic Resonance Scanner, the MR examination of the human knee, foot, ankle, hand and wrist.
Used in the MAGNETOM ESSENZA, the 14-Channel Extremity Coil is indicated for use as a magnetic resonance diagnostic device (MRDD) to produce transverse, sagittal, coronal and oblique cross sectional images that display the internal structure and/or function of the knee, foot, ankle, hand and wrist. The images produced by the MAGNETOM ESSENZA with the 14-Channel Extremity Coil reflects 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 ESSENZA is not affected in any way by the use of the new 14-Channel Extremity Coil.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100141 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100141: 14-Channel Extremity Coil for Magnetom Essenza.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100141
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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