510(k) · Cleared
ClearedModel 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64:
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Advances, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 26, 1997 after an 89-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Feb 26, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK964813 Model 675GE-64 Peripheral Vascular Coil Consisting of Model…Medical Advances, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK982339 Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK023247 Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK042207 11000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K982339Flow 7000 Peripheral Vascular CoilUsa Instruments, Inc. · 1998 · cites it directly2descendants
- K023247Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc. · 2002 · 2 generations on1descendant
- K04220711000 Rapture Phased Array Peripheral Vascular CoilUsa Instruments, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964813 | Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower… | Medical Advances, Inc. | 1997 | — |
| +1 | K982339 | Flow 7000 Peripheral Vascular Coil | Usa Instruments, Inc. | 1998 | — |
| +2 | K023247 | Champion 5000 Peripheral Vascular Coil | Usa Instruments, Inc. | 2002 | — |
| +2 | K042207 | 11000 Rapture Phased Array Peripheral Vascular Coil | Usa Instruments, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982339 | Flow 7000 Peripheral Vascular Coil | 1998 | 2 |
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?
- Of its descendants, K982339 (Usa Instruments, Inc., 1998) has gone furthest, with 2 descendants of its own.
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?
2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging.
Vascular structures, soft tissue and musculosketeal structures in the lower extremities (mid-abdomen to mid-foot)
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/K964813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964813: Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64:.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964813
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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