510(k) · Cleared
ClearedSonoheart Hand-Carried Echocardiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 20, 1999 as substantially equivalent to K991710 (Toshiba America Medical Systems, In.C, 1999) and 3 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1989. 3 of the 218 devices in its family, counting itself, have a Class I recall. 196 later devices descend from it.
- Decided
- Dec 20, 1999
- Review
- 17 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K894632 (1989). 21 ancestors in all, the oldest K891453 (1989). 196 later devices descend from it, 2 citing it directly. 3 of the 218 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 3 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 2 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 1 generation backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- This deviceK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- Descendant · cites it directly · 135 of its ownK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 130 of its ownK092756 GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009
- Descendant · 2 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- Descendant · 3 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Showing 5 of 196 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 196 · See all- K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · cites it directly135descendants
- K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009 · 2 generations on130descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 2 generations on107descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 3 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −3 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −2 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −1 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| 0 (this device) | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| +1 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K092756 | GE Vscan Compact Diagnostic Ultrasound System | Ge Vingmed Ultrasound AS | 2009 | — |
| +2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| +3 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +4 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 18 | 1 |
| 2021 | 14 | 0 |
| 2022 | 14 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 25 | 2 |
| 2026 | 19 | 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.
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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K991710 | Ssa-370A/Powervision 6000Summary page 2…n SonoHeart™ Hand-Carried Echocardiography System Addition of PowerMap™ Directional Color Power Doppler — November 3, 1999 Revision A marketed Toshiba PowerVision 6000 (K991710), and the General Electric LOGIQ 500 MD (K991611), and the previously cleared SonoSite™ 180 Hand-Carried Ultrasound System (K9908… | 1999 |
| * | K991611 | GE Logiq 500Summary page 2…Addition of PowerMap™ Directional Color Power Doppler — November 3, 1999 Revision A marketed Toshiba PowerVision 6000 (K991710), and the General Electric LOGIQ 500 MD (K991611), and the previously cleared SonoSite™ 180 Hand-Carried Ultrasound System (K990806 and KS81505). 4) Device Description: The Son… | 1999 |
| * | K990806 | C1 Ultrasound SystemSummary page 2…A marketed Toshiba PowerVision 6000 (K991710), and the General Electric LOGIQ 500 MD (K991611), and the previously cleared SonoSite™ 180 Hand-Carried Ultrasound System (K990806 and KS81505). 4) Device Description: The SonoHeart™ Hand-Carried Echocardiography System is a general purpose, highly portable,… | 1999 |
| * | K981505 | Cozumel Diagnostic Ultrasound SystemSummary page 8…er Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505. Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power… | 1998 |
What descends from it? (196)
See all 1962 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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K063761 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 135 descendants of its own.
- 1 other device also cites its predicate K991710.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
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.
https://510kreport.com/device/K994096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994096: Sonoheart Hand-Carried Echocardiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994096
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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