510(k) · Cleared
ClearedLeo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 21, 2003 as substantially equivalent to K002179 (Siemens Medical Solutions USA, Inc., 2000) and 3 other predicates after an 81-day review. Its family tree reaches back 3 generations to 1989. 22 later devices descend from it.
- Decided
- Feb 21, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K893619 (1989). 12 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
- 2 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
- 1 generation backK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
- This deviceK023982 Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist…Usa Instruments, Inc. · 2003
- Descendant · cites it directly · 21 of its ownK082636 TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · Recalled
- Descendant · 2 generations on · 12 of its ownK100141 14-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010
- Descendant · 3 generations on · 11 of its ownK130262 Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013
- Descendant · 4 generations on · 9 of its ownK152283 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 5 generations on · 7 of its ownK173600 MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K082636TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TQuality Electrodynamics · 2008 · cites it directly21descendants
- K10014114-Channel Extremity Coil for Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2010 · 2 generations on12descendants
- K130262Magnetom Essenza with Syngo MR D14Siemens Medical Solutions USA, Inc. · 2013 · 3 generations on11descendants
- K152283MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2015 · 4 generations on9descendants
- K173600MAGNETOM AmiraSiemens Medical Solutions USA, Inc. · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893619 | Vista MR 2055 HP System | Philips Medical Systems (Cleveland), Inc. | 1989 | — |
| −2 | K960497 | Flexible Phased Array Spine Coil | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −1 | K971246 | Leo 7000 Quadrature Knee Coil | Usa Instruments, Inc. | 1997 | — |
| 0 (this device) | 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 |
| +2 | K100141 | 14-Channel Extremity Coil for Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +3 | K130262 | Magnetom Essenza with Syngo MR D14 | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +4 | K152283 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +5 | K173600 | MAGNETOM Amira | Siemens Medical Solutions USA, Inc. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K002179 | Magnetom Allegra System | 2000 |
| * | K971246 | Leo 7000 Quadrature Knee CoilSummary page 2…(KO02179) -Similar to the Leo 7000 Knee Coil manufactured by USA Instruments, Inc. (K971246) Indications for Use: Identical to routine - Similar to the Allegra 3.0Tesla TxRx Head coil MRI imaging.… | 1997 |
| * | K001210 | HI-Res 9000 Phased Array Carotid CoilSummary page 2…to the Hi-Res 9000 Phased Array Carotid Flame Retardant Polyurethane Coil manufactured by USA Instruments, Inc. Flame Retardant Polycarbonate (K001210) Kydex Acyrlic/PVC Delrin Acetal Coil Design: 12 z-inductor transmit - Similar to the Allegra 3.0Tesla TxRx Head coil receive… | 2000 |
| * | K972205 | Alpha 7000 Quadrature Wrist CoilSummary page 4…nd -Similar to the Alpha 7000 Wrist Coil manufactured by USA Instruments, Inc. (K972205) Indications for Use: Identical to routine -Similar to the Alpha 7000 Wrist Coil manufactured MRI imaging.… | 1997 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T | 2008 | 21 |
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 14 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K082636 (Quality Electrodynamics, 2008) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K002179.
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 Leo Ill Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha Ill Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo Ill Tx/Rx Quadrature Knee Coil and the Alpha 111 Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.OT scanner manufactured by Siemens Medical Solutions. Anatomic Regions: Leo 111…
Read the full statement (180 words)
The Leo Ill Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha Ill Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo Ill Tx/Rx Quadrature Knee Coil and the Alpha 111 Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.OT scanner manufactured by Siemens Medical Solutions.
Anatomic Regions:
Leo 111 Tx/Rx Quadrature Knee Coil: Knee and surrounding Anatomy
Alpha IIII Tx/Rx Quadrature Wrist Coil: Wrist and Hand
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.OT MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023982 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023982: Leo Iii TX/RX Quadrature Knee Coil; Alpha Iii TX/RX Quadrature Wrist Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023982
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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