510(k) · Cleared
ClearedPhased Array Knee and Foot 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 Jan 18, 2000 as substantially equivalent to K971246 (Usa Instruments, Inc., 1997) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Jan 18, 2000
- Review
- 50 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K893619 (1989). 8 ancestors in all. 1 later device descends 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 deviceK994040 Phased Array Knee and Foot CoilUsa Instruments, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK013592 Extremity CoilUsa Instruments, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K013592Extremity CoilUsa Instruments, Inc. · 2002 · cites it directly0descendants
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) | K994040 | Phased Array Knee and Foot Coil | Usa Instruments, Inc. | 2000 | — |
| +1 | K013592 | Extremity Coil | Usa Instruments, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K971246 | Leo 7000 Quadrature Knee CoilSummary page 2…or other 510(k) cleared product G Intended Use: Knee and Foot Imaging Applications -Similar to the Leo 7000 Quadrature Knee Coil manufactured by USA Instruments, Inc. (K971246) -Similar to the Model 473S1-42D Quadrature Lower Extremity Coil manufactured by Medical Advances, Inc. (K982496) Indications fo… | 1997 |
| * | K982496 | Quadrature Lower Extremity Coil, Model # 473SI-42DSummary page 2…drature Knee Coil manufactured by USA Instruments, Inc. (K971246) -Similar to the Model 473S1-42D Quadrature Lower Extremity Coil manufactured by Medical Advances, Inc. (K982496) Indications for Use: Identical to routine MRI imaging -Similar to the Leo 7000 Quadrature Knee Coil manufactured by USA Instru… | 1998 |
| † | K980157 | Premier 7000 CTL Spine Coil | 1998 |
| † | K983143 | Mark 5000 Phased Array Shoulder Coil | 1998 |
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 |
|---|---|---|---|
| K013592 | Extremity Coil | 2002 | 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 11 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K013592 (Usa Instruments, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K971246.
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 Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner. Anatomic Regions: Knee and Foot Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa HFO/i 0.7T system is indicated for use as an NMR device that produces images that: (1) correspond to the…
Read the full statement (134 words)
The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner.
Anatomic Regions: Knee and Foot
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa HFO/i 0.7T 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994040: Phased Array Knee and Foot Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994040
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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