510(k) · Cleared
CleareddS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invivo Corporation · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 23, 2021 as substantially equivalent to K162177 (Invivo Corporation, 2016) and 2 other predicates after a 22-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Dec 23, 2021
- Review
- 22 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K983109 (1998). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983109 Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model…Medical Advances, Inc. · 1998
- 2 generations backK091902 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel…Invivo · 2009
- 1 generation backK162863 dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation · 2016
- This deviceK213766 dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch…Invivo Corporation · 2021
- Descendant · cites it directly · 0 of its ownK262294 dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist…Philips Medical Systems Nederland B.V. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…Philips Medical Systems Nederland B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983109 | Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model 543GE-64… | Medical Advances, Inc. | 1998 | — |
| −2 | K091902 | 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel Small… | Invivo | 2009 | — |
| −1 | K162863 | dS Small Extremity 16CH 1.5T Coil | Invivo Therapeutics Corporation | 2016 | — |
| 0 (this device) | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for… | Invivo Corporation | 2021 | — |
| +1 | K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS… | Philips Medical Systems Nederland B.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K162177 | dS FootAnkle I6CH 1.5T CoilSummary page 6…Device Class: Class II Product Code: MOS Primary dS FootAnkle 16Ch Coil for 1.5T, Invivo Corporation, K162177 Predicate cleared on 09/14/2016 Devices: Hand-Wrist Coil 16Ch Coil for 1.5T, Invivo Corporation, K103… | 2016 |
| * | K103149 | 1.5T 16-Channel Hand-Wrist CoilSummary page 6…h Coil for 1.5T, Invivo Corporation, K162177 Predicate cleared on 09/14/2016 Devices: Hand-Wrist Coil 16Ch Coil for 1.5T, Invivo Corporation, K103149 cleared on 01/03/2010 dS Small Extremity 16Ch 1.5T Coil, Invivo Corporation, K162863… | 2011 |
| * | K162863 | dS Small Extremity 16CH 1.5T CoilSummary page 6…t Coil 16Ch Coil for 1.5T, Invivo Corporation, K103149 cleared on 01/03/2010 dS Small Extremity 16Ch 1.5T Coil, Invivo Corporation, K162863 cleared on 11/7/2016 Page 1 of 5… | 2016 |
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 |
|---|---|---|---|
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes… | 2026 | 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 23 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K262294 (Philips Medical Systems Nederland B.V., 2026) has gone furthest, with 0 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. 2021, 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 dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy that can be interpreted by a trained physician. The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be…
Read the full statement (126 words)
The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy that can be interpreted by a trained physician.
The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be interpreted by a trained physician.
The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the small extremities anatomy on adult and pediatric patients that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213766 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213766: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213766
Report an extraction error
Are you the manufacturer?
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