510(k) Report

510(k) · Cleared

Cleared

Sonixtouch Ultrasound System

K083095510(k) TraditionalCleared Oct 31, 200814-day reviewClass II21 CFR 892.1550

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

Ultrasonix Medical Corporation · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 31, 2008 as substantially equivalent to K080935 (Ultrasonix Medical Corporation, 2008) and 7 other predicates after a 14-day review. Its family tree reaches back 11 generations to 1995. 582 later devices descend from it.

Decided
Oct 31, 2008
Review
14 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
8

Its longest line of descent runs back 11 generations to K935595 (1995). 87 ancestors in all, the oldest K891689 (1989). 582 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2006: 5 other ancestors2005: 8 other ancestors2004: 10 other ancestors2003: 8 other ancestors2002: 6 other ancestors2001: 6 other ancestors2000: 6 other ancestors1998: 2 other ancestors1997: 6 other ancestors1995: 5 other ancestors1999: 6 other ancestors1994: 4 other ancestors1992: 1 other ancestor1989: 1 other ancestor2009: 3 descendants cleared2017: 49 descendants cleared2010: 4 descendants cleared2020: 52 descendants cleared2014: 34 descendants cleared2011: 10 descendants cleared2012: 20 descendants cleared2013: 19 descendants cleared2022: 43 descendants cleared2025: 47 descendants cleared2015: 29 descendants cleared2016: 37 descendants cleared2018: 48 descendants cleared2019: 35 descendants cleared2023: 38 descendants cleared2021: 38 descendants cleared2024: 45 descendants cleared2026: 31 descendants clearedK935595 · Acuson Model 3001 · Acuson Corp. · 1995K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003×3: 3 generations cleared close together, K041319 (2004), K042770 (2004), K050240 (2005) K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalled×2: 2 generations cleared close together, K063138 (2006), K063803 (2007) K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 16 other ancestors3 generations back: 14 other ancestors4 generations back: 9 other ancestors5 generations back: 6 other ancestors6 generations back: 5 other ancestors7 generations back: 9 other ancestors8 generations back: 10 other ancestors 1 generation forward: 6 descendants2 generations forward: 16 descendants3 generations forward: 28 descendants4 generations forward: 63 descendants5 generations forward: 91 descendants6 generations forward: 93 descendants7 generations forward: 72 descendants8 generations forward: 72 descendants9 generations forward: 50 descendants10 generations forward: 44 descendants11 generations forward: 20 descendants12 generations forward: 14 descendants13 generations forward: 7 descendants14 generations forward: 5 descendants15 generations forward: 1 descendant K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K063803 · Acuson Antares Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · recalledK063138 · Modification to Acuson Antares Ultrasound System · Siemens Medical Solutions USA, Inc. · 2006K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK050240 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK042770 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK041319 · Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2004K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K935595 · Acuson Model 3001 · Acuson Corp. · 1995−10−50+5+10+15
  1. Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 7 generations between
  3. 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  4. 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  5. 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  6. This deviceK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
  7. Descendant · cites it directly · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
  8. Descendant · 2 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
  9. Descendant · 3 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
  10. Descendant · 2 generations on · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
  11. Descendant · 3 generations on · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
Show all 11 generations
  1. Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. 6 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  7. 5 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  8. 4 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  9. 3 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  10. 2 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  11. 1 generation backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  12. This deviceK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008

Showing 5 of 582 descendants. See all descendants

Descendants cleared per year

2009: 32010: 42011: 102012: 202013: 192014: 342015: 292016: 372017: 492018: 482019: 352020: 522021: 382022: 432023: 382024: 452025: 472026: 31
2009high 52 (2020) · low 3 (2009)2026

Most influential descendants

Showing 5 of 582 · See all
  • K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · cites it directly569descendants
  • K110943Logiq E9GE Healthcare · 2011 · 2 generations on472descendants
  • K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 3 generations on469descendants
  • K111582Logiq S8GE Healthcare · 2011 · 2 generations on367descendants
  • K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 3 generations on365descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K935595Acuson Model 3001Acuson Corp.1995—
−10K973767Harmonic Imaging with ContrastAcuson Corp.1997—
−9K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
−8K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
−7K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
−6K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20041
−5K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20051
−4K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
−3K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—
−2K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20079
−1K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
0 (this device)K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008—
+1K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20091
+2K110943Logiq E9GE Healthcare20112
+3K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20111
+2K111582Logiq S8GE Healthcare20113
+3K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
199440
199550
199760
199820
199960
200060
200160
200260
200380
2004100
200580
200650
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201040
2011100
2012200
2013190
2014340
2015290
2016370
2017490
2018480
2019350
2020520
2021380
2022430
2023380
2024450
2025470
2026310
FIG. 1 — Lineage of K083095, 1995–2026Source: 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 IYN? 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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (8)

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
*K080935Sonix MDP Ultrasound Scanner
Summary page 2
…Page 7 of 40 2.4 Classification Class Il 2.5 Predicate Device: SONIX MDP Ultrasound Scanner (K080935) SONIX Ultrasound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnos…
Ultrasonix Medical Corporation2008—
*K061827Sonix Ultrasound Scanner
Summary page 2
…Page 7 of 40 2.4 Classification Class Il 2.5 Predicate Device: SONIX MDP Ultrasound Scanner (K080935) SONIX Ultrasound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE…
Ultrasonix Medical Corporation2006—
*K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)
Summary page 2
…Class Il 2.5 Predicate Device: SONIX MDP Ultrasound Scanner (K080935) SONIX Ultrasound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) S…
Sonosite,Inc.20053
*K062247HD11 Diagnostic Ultrasound System
Summary page 2
…Scanner (K080935) SONIX Ultrasound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) V…
Philips Ultrasound, Inc.20063
*K060993GE Logiq P5 and A5
Summary page 2
…asound Scanner (K061827) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound…
General Electric Co.2006—
*K080223Zura Tee System
Summary page 2
…MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound Systems (K061215) 2.6 Reason for su…
Imacor, LLC20081
*K072786Acuson S2000 Ultrasound System
Summary page 2
…Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound Systems (K061215) 2.6 Reason for submission: Name change request N/A New…
Siemens Medical Solutions USA, Inc.2007—
*K061215Volcano S51 Family of Imaging Systems
Summary page 2
…GE Logiq P5 and A5 (K060993) Imacor Zura TEE System (K080223) Siemens S2000 Diagnostic Ultrasound System (K072786) Volcano S5i Family of Ultrasound Systems (K061215) 2.6 Reason for submission: Name change request N/A New product clearance for: SonixTouch Ultr…
Volcano Corporation2006—

Also cleared against K080935: 3 other devices →

What descends from it? (582)

See all 582

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare2009569
K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979
K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077
K083421MR-Touch OptionGe Medical Systems, LLC20094
K100989Zura Tee System with Claritee ProbeImacor, Inc.20101
K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170

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 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 22 of the 87 ancestors have a recall of any class.
  • Of its descendants, K092271 (GE Healthcare, 2009) has gone furthest, with 569 descendants of its own.
  • 3 other devices also cite its predicate K080935.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

The SonixTouch Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access, Transcranial. The system also provides the ability to measure…

Read the full statement (88 words)

The SonixTouch Ultrasound Scanner is intended for the following applications:

Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative

Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN,

Transesophageal, Transrectal, Transvaginal, Peripheral Vascular,

Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block,

Vascular Access, Transcranial.

The system also provides the ability to measure anatomical structures {fetal,

abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral

vessel, musculoskeletal} and provides calculation packages that provide

information to the clinician that may be used adjunctively with other medical data

obtained by a physician for clinical diagnosis purposes.

Indications for use as stated in the FDA summary.

Also cleared against K080935

3 other devices cite the same predicate.

  • K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc. · 2019
  • K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010
  • K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2009

More from Ultrasonix Medical Corporation

11 FDA decisions under this applicant name. See the company

  • K121812SonixgpsUltrasonix Medical Corporation · 2013
  • K111818Sonixgps Needle SensorUltrasonix Medical Corporation · 2012
  • K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2012
  • K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2011
  • K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K083095 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083095: Sonixtouch Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083095

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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