510(k) Report

510(k) · Cleared

Cleared

Sonix Ultrasound Scanner

K093462510(k) TraditionalCleared Nov 20, 200914-day reviewClass II21 CFR 892.1570

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

Ultrasonix Medical Corporation · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Nov 20, 2009 as substantially equivalent to K083095 (Ultrasonix Medical Corporation, 2008) and 10 other predicates after a 14-day review. Its family tree reaches back 12 generations to 1995. 79 later devices descend from it.

Decided
Nov 20, 2009
Review
14 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
11

Its longest line of descent runs back 12 generations to K935595 (1995). 106 ancestors in all, the oldest K882383 (1988). 79 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 3 other ancestors2007: 2 other ancestors2006: 5 other ancestors2005: 10 other ancestors1998: 3 other ancestors2004: 12 other ancestors2003: 11 other ancestors2001: 6 other ancestors1997: 6 other ancestors1995: 6 other ancestors1993: 1 other ancestor1988: 1 other ancestor2002: 7 other ancestors2000: 6 other ancestors1999: 6 other ancestors1996: 1 other ancestor1994: 5 other ancestors1991: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor2011: 1 descendant cleared2010: 1 descendant cleared2014: 5 descendants cleared2012: 2 descendants cleared2013: 1 descendant cleared2015: 3 descendants cleared2016: 4 descendants cleared2017: 6 descendants cleared2018: 5 descendants cleared2021: 7 descendants cleared2025: 7 descendants cleared2020: 7 descendants cleared2022: 8 descendants cleared2019: 5 descendants cleared2024: 7 descendants cleared2023: 6 descendants cleared2026: 4 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. · 2007K083095 · Sonixtouch Ultrasound System · Ultrasonix Medical Corporation · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 20 other ancestors3 generations back: 23 other ancestors4 generations back: 9 other ancestors5 generations back: 7 other ancestors6 generations back: 7 other ancestors7 generations back: 9 other ancestors8 generations back: 10 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 8 descendants5 generations forward: 13 descendants6 generations forward: 13 descendants7 generations forward: 6 descendants8 generations forward: 11 descendants9 generations forward: 5 descendants10 generations forward: 8 descendants11 generations forward: 4 descendants12 generations forward: 1 descendant13 generations forward: 1 descendant K083095 · Sonixtouch Ultrasound System · Ultrasonix Medical Corporation · 2008K072786 · 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
  1. Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 8 generations between
  3. 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  4. 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  5. 1 generation backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
  6. This deviceK093462 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2009
  7. Descendant · cites it directly · 77 of its ownK102997 Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010
  8. Descendant · 2 generations on · 75 of its ownK113663 Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2012
  9. Descendant · 2 generations on · 74 of its ownK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
  10. Descendant · 3 generations on · 73 of its ownK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
  11. Descendant · 4 generations on · 60 of its ownK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
Show all 12 generations
  1. Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  7. 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  8. 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  9. 4 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  10. 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  11. 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  12. 1 generation backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
  13. This deviceK093462 Sonix Ultrasound ScannerUltrasonix Medical Corporation · 2009

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 22013: 12014: 52015: 32016: 42017: 62018: 52019: 52020: 72021: 72022: 82023: 62024: 72025: 72026: 4
2010high 8 (2022) · low 1 (2010)2026

Most influential descendants

Showing 5 of 79 · See all
  • K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010 · cites it directly77descendants
  • K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2012 · 2 generations on75descendants
  • K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on74descendants
  • K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · 3 generations on73descendants
  • K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · 4 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K935595Acuson Model 3001Acuson Corp.1995—
−11K973767Harmonic Imaging with ContrastAcuson Corp.1997—
−10K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
−9K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
−8K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
−7K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20041
−6K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20051
−5K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
−4K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—
−3K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20079
−2K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
−1K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008—
0 (this device)K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation2009—
+1K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation2010—
+2K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation2012—
+2K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.20122
+3K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro20133
+4K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199110
199210
199310
199450
199560
199610
199760
199830
199960
200060
200160
200270
2003110
2004120
2005100
200650
200720
200830

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201220
201310
201450
201530
201640
201760
201850
201950
202070
202170
202280
202360
202470
202570
202640
FIG. 1 — Lineage of K093462, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 ITX? 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 ITX device

  1. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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? (11)

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
*K083095Sonixtouch Ultrasound System
Summary page 2
…Page 7 of 37 2.4 Classification Class II 2.5 Predicate Device: Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) SonoSite M…
Ultrasonix Medical Corporation2008—
*K080935Sonix MDP Ultrasound Scanner
Summary page 2
…Page 7 of 37 2.4 Classification Class II 2.5 Predicate Device: Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) SonoSite MicroMaxx High Resolution Ultrasound System…
Ultrasonix Medical Corporation2008—
*K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2
Summary page 2
…Page 2 === 2.4 Classification Class II 2.5 Predicate Device: Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD…
Ge Medical Systems Ultrasound and Primary Care Dia20081
*K974432Ultraguide 1000
Summary page 2
…n Class II 2.5 Predicate Device: Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound Syst…
Ultraguide, Ltd.1998—
*K070244AEGIS
Summary page 2
…Predicate Device: Sonix TOUCH Ultrasound Scanner (K083095) SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) SonoSite MicroMaxx High Resolution Ultrasound System (K053069) Philips HD 11 Diagnostic Ultrasound System (K062247) GE…
Sentinelle Medical, Inc.2007—
*K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)
Summary page 2
…SONIX MDP Ultrasound Scanner (K080935) GE Logiq E9 (K082185) Ultraguide 1000 (K974432) Aegis (K070244) 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
…K082185) Ultraguide 1000 (K974432) Aegis (K070244) 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
…4432) Aegis (K070244) 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: Clearance request for: Son…
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: Clearance request for: Sonix Ultrasound Scanner and the cleared transducers with…
Volcano Corporation2006—

Also cleared against K083095: 5 other devices →

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077
K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110

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 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 25 of the 106 ancestors have a recall of any class.
  • Of its descendants, K102997 (Ultrasonix Medical Corporation, 2010) has gone furthest, with 77 descendants of its own.
  • 5 other devices also cite its predicate K083095.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

What is it indicated for?

The Sonix 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 Sonix 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 K083095

5 other devices cite the same predicate.

  • K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc. · 2017
  • K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation · 2010
  • K100989Zura Tee System with Claritee ProbeImacor, Inc. · 20101 recall
  • K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 20091 recall
  • K083421MR-Touch OptionGe Medical Systems, LLC · 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 ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K093462 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093462: Sonix Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093462

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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