510(k) Report

510(k) · Cleared

Cleared

Titan High Resolution Ultrasound System

K030949510(k) TraditionalCleared Apr 7, 200312-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

Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 7, 2003 as substantially equivalent to K011224 (Advanced Technology Laboratories, Inc., 2001) and 2 other predicates after a 12-day review. Its family tree reaches back 2 generations to 1995. 683 later devices descend from it.

Decided
Apr 7, 2003
Review
12 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K945773 (1995). 5 ancestors in all. 683 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1995: 1 other ancestor2004: 1 descendant cleared2003: 1 descendant cleared2010: 8 descendants cleared2005: 2 descendants cleared2007: 2 descendants cleared2009: 5 descendants cleared2008: 5 descendants cleared2013: 25 descendants cleared2012: 25 descendants cleared2014: 39 descendants cleared2011: 14 descendants cleared2015: 38 descendants cleared2019: 40 descendants cleared2017: 53 descendants cleared2016: 48 descendants cleared2020: 57 descendants cleared2025: 54 descendants cleared2018: 52 descendants cleared2023: 42 descendants cleared2021: 42 descendants cleared2022: 47 descendants cleared2026: 35 descendants cleared2024: 48 descendants clearedReference device: K003399 · Sonosite Hand-Carried Ultrasound System · Sonosite,Inc. · 2000Reference device: K023957 · Sonosite Hand-Carried Ultrasound System (C2 Series) · Sonosite,Inc. · 2002K945773 · Siemens Sonoline Versa · Siemens Medical Solutions USA, Inc. · 1995K020353 · Omnia X/XS Ultrasound System · Siemens Medical Systems, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 21 descendants4 generations forward: 33 descendants5 generations forward: 61 descendants6 generations forward: 84 descendants7 generations forward: 98 descendants8 generations forward: 100 descendants9 generations forward: 79 descendants10 generations forward: 65 descendants11 generations forward: 44 descendants12 generations forward: 28 descendants13 generations forward: 26 descendants14 generations forward: 12 descendants15 generations forward: 11 descendants16 generations forward: 5 descendants17 generations forward: 4 descendants K020353 · Omnia X/XS Ultrasound System · Siemens Medical Systems, Inc. · 2002K945773 · Siemens Sonoline Versa · Siemens Medical Solutions USA, Inc. · 19950+5+10+15
  1. Root · 2 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
  2. 1 generation backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
  3. This deviceK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
  4. Descendant · cites it directly · 678 of its ownK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  6. Descendant · 3 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
  7. Descendant · 2 generations on · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled
  8. Descendant · 3 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008

Showing 5 of 683 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22007: 22008: 52009: 52010: 82011: 142012: 252013: 252014: 392015: 382016: 482017: 532018: 522019: 402020: 572021: 422022: 472023: 422024: 482025: 542026: 35
2003high 57 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 683 · See all
  • K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · cites it directly678descendants
  • K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · 2 generations on676descendants
  • K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 3 generations on584descendants
  • K080223Zura Tee SystemImacor, LLC · 2008 · 2 generations on583descendants
  • K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 3 generations on582descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945773Siemens Sonoline VersaSiemens Medical Solutions USA, Inc.1995—
−1K020353Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc.2002—
0 (this device)K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003—
+1K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20054
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20053
+3K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008—
+2K080223Zura Tee SystemImacor, LLC20081
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
200720
200850
200950
201080
2011140
2012250
2013250
2014390
2015380
2016480
2017530
2018520
2019400
2020570
2021420
2022470
2023420
2024480
2025540
2026350
FIG. 1 — Lineage of K030949, 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 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? (3)

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
*K011224Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…Advanced Technology Laboratories, Inc.2001—
*K011188GE Logiq 9, Model 2188900-XGE Medical Systems2001—
*K020353Omnia X/XS Ultrasound System
Summary page 1
…KO11224), the GE LOGIQ 9 Diagnostic Ultrasound System (KO11188) and the Siemens OMNIA WXS Diagnostic Ultrasound System (K020353). 51O(K) Summary Of Safety And Effectiveness Page 1 of 6…
Siemens Medical Systems, Inc.2002—
†K003399Sonosite Hand-Carried Ultrasound SystemSonosite,Inc.2000—
†K023957Sonosite Hand-Carried Ultrasound System (C2 Series)Sonosite,Inc.2002—

Also cleared against K011224: 9 other devices →

What descends from it? (683)

See all 683

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

NumberDeviceApplicantDecidedDescendants
K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.2005678
K033367Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Sonosite,Inc.200313
K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc.200411
K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.201010

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 8 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K043559 (Sonosite,Inc., 2005) has gone furthest, with 678 descendants of its own.
  • 9 other devices also cite its predicate K011224.

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.

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 intended uses of the SonoSite TITAN high-resolution ultrasound system as defined by FDA guidance documents, are:

Fetal - OB/GYN

Abdominal

Intra-operative (Abdominal organs and vascular)

Laparoscopic

Pediatric

Small Organ (breast, thyroid, testicles.)

Neonatal Cephalic

Adult Cephalic

Trans-rectal

Trans-vaginal

Trans-urethral

Musculo-skel. (Conventional)

Musculo-skel. (Superficial)

Cardiac Adult

Cardiac Pediatric

Peripheral vessel

Indications for use as stated in the FDA summary.

Also cleared against K011224

9 other devices cite the same predicate.

  • K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 20092 recalls
  • K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 20082 recalls
  • K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 20072 recalls
  • K053648Pioneer TC8080, Companion IiiViasys Neuro Care · 2006
  • K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 20053 recalls
  • K052109Sonosite Hand-Carried Ultrasound System (C1 Series)Sonosite,Inc. · 2005

More from Sonosite,Inc.

23 FDA decisions under this applicant name. See the company

  • K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 20111 recall
  • K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011
  • K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
  • K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 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/K030949 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030949: Titan High Resolution Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030949

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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