510(k) · Cleared
ClearedVingmed Sound Color Flow Mapping System. System Five
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vingmed Sound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 17, 1997 after a 207-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 406 devices in its family, counting itself, have a Class I recall. 405 later devices descend from it.
- Decided
- Mar 17, 1997
- Review
- 207 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
405 later devices descend from it, 2 citing it directly. 3 of the 406 devices in this family, counting this one, have a Class I recall.
- This deviceK963315 Vingmed Sound Color Flow Mapping System. System FiveVingmed Sound, Inc. · 1997
- Descendant · cites it directly · 403 of its ownK981397 Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic…Toshiba America Medical Systems, In.C · 1998
- Descendant · 2 generations on · 212 of its ownK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- Descendant · 3 generations on · 211 of its ownK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- Descendant · 4 generations on · 210 of its ownK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- Descendant · cites it directly · 210 of its ownK991842 System Five/Echopac with Strain Rate ImagingGe Vingmed Ultrasound · 1999
Showing 5 of 405 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 405 · See all- K981397Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System…Toshiba America Medical Systems, In.C · 1998 · cites it directly403descendants
- K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999 · 2 generations on212descendants
- K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001 · 3 generations on211descendants
- K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · 4 generations on210descendants
- K991842System Five/Echopac with Strain Rate ImagingGe Vingmed Ultrasound · 1999 · cites it directly210descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963315 | Vingmed Sound Color Flow Mapping System. System Five | Vingmed Sound, Inc. | 1997 | — |
| +1 | K981397 | Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound… | Toshiba America Medical Systems, In.C | 1998 | — |
| +2 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| +3 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| +4 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| +1 | K991842 | System Five/Echopac with Strain Rate Imaging | Ge Vingmed Ultrasound | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 11 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 12 | 0 |
| 2013 | 6 | 0 |
| 2014 | 18 | 0 |
| 2015 | 13 | 0 |
| 2016 | 18 | 0 |
| 2017 | 22 | 0 |
| 2018 | 28 | 0 |
| 2019 | 18 | 0 |
| 2020 | 35 | 1 |
| 2021 | 24 | 0 |
| 2022 | 28 | 0 |
| 2023 | 30 | 0 |
| 2024 | 25 | 0 |
| 2025 | 48 | 2 |
| 2026 | 32 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (405)
See all 4052 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K981397 (Toshiba America Medical Systems, In.C, 1998) has gone furthest, with 403 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K963315 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963315: Vingmed Sound Color Flow Mapping System. System Five.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963315
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026