510(k) Report

510(k) · Cleared

Cleared

System Five/Echopac with Strain Rate Imaging

K991842510(k) TraditionalCleared Jun 11, 199914-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Vingmed Ultrasound · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 11, 1999 as substantially equivalent to K963315 (Vingmed Sound, Inc., 1997) after a 14-day review. Its family tree reaches back 1 generation to 1997. 210 later devices descend from it.

Decided
Jun 11, 1999
Review
14 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963315 (1997). 210 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2005: 2 descendants cleared2007: 3 descendants cleared2008: 5 descendants cleared2015: 5 descendants cleared2009: 5 descendants cleared2017: 12 descendants cleared2016: 7 descendants cleared2013: 4 descendants cleared2011: 4 descendants cleared2012: 8 descendants cleared2018: 18 descendants cleared2010: 1 descendant cleared2014: 10 descendants cleared2019: 8 descendants cleared2023: 18 descendants cleared2025: 26 descendants cleared2020: 20 descendants cleared2021: 9 descendants cleared2026: 13 descendants cleared2022: 16 descendants cleared2024: 13 descendants clearedK963315 · Vingmed Sound Color Flow Mapping System. System Five · Vingmed Sound, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 7 descendants6 generations forward: 7 descendants7 generations forward: 15 descendants8 generations forward: 23 descendants9 generations forward: 21 descendants10 generations forward: 31 descendants11 generations forward: 25 descendants12 generations forward: 21 descendants13 generations forward: 19 descendants14 generations forward: 9 descendants15 generations forward: 7 descendants16 generations forward: 7 descendants17 generations forward: 4 descendants18 generations forward: 3 descendants K963315 · Vingmed Sound Color Flow Mapping System. System Five · Vingmed Sound, Inc. · 19970+5+10+15
  1. Root · 1 generation backK963315 Vingmed Sound Color Flow Mapping System. System FiveVingmed Sound, Inc. · 1997
  2. This deviceK991842 System Five/Echopac with Strain Rate ImagingGe Vingmed Ultrasound · 1999
  3. Descendant · cites it directly · 209 of its ownK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
  4. Descendant · 2 generations on · 205 of its ownK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
  5. Descendant · 3 generations on · 203 of its ownK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
  6. Descendant · 3 generations on · 182 of its ownK072826 Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2007
  7. Descendant · 4 generations on · 181 of its ownK080160 Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2008

Showing 5 of 210 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22006: 12007: 32008: 52009: 52010: 12011: 42012: 82013: 42014: 102015: 52016: 72017: 122018: 182019: 82020: 202021: 92022: 162023: 182024: 132025: 262026: 13
2003high 26 (2025) · low 1 (2003)2026

Most influential descendants

Showing 5 of 210 · See all
  • K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003 · cites it directly209descendants
  • K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · 2 generations on205descendants
  • K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007 · 3 generations on203descendants
  • K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2007 · 3 generations on182descendants
  • K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2008 · 4 generations on181descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963315Vingmed Sound Color Flow Mapping System. System FiveVingmed Sound, Inc.1997—
0 (this device)K991842System Five/Echopac with Strain Rate ImagingGe Vingmed Ultrasound1999—
+1K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003—
+2K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20061
+3K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007—
+3K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007—
+4K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200610
200730
200850
200950
201010
201140
201280
201340
2014100
201550
201670
2017120
2018180
201980
2020200
202190
2022160
2023180
2024130
2025260
2026130
FIG. 1 — Lineage of K991842, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 IYO? 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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963315Vingmed Sound Color Flow Mapping System. System Five
Summary page 1
…rain Rate Imaging Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO GE Vingmed Ultrasound System FiVe diagnostic ultrasound system / EchoPac, 510(k) Number K963315, currently in commercial distribution. Strain Rate Imaging is a modification to the motion analysis capability of the System FiV…
Vingmed Sound, Inc.1997—

Also cleared against K963315: 1 other device →

What descends from it? (210)

See all 210

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209

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?

  • Its one ancestor has no recall.
  • Of its descendants, K032281 (Toshiba America Medical Systems, In.C, 2003) has gone furthest, with 209 descendants of its own.
  • 1 other device also cites its predicate K963315.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963315

1 other device cites the same predicate.

  • K981397Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System Ssa-380A, Powervision…Toshiba America Medical Systems, In.C · 1998

Recent decisions in IYO

The IYO category page

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  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K991842 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991842: System Five/Echopac with Strain Rate Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991842

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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