510(k) Report

510(k) · Cleared

Recalled · 2011

Sonosite Maxx Series Ultrasound System

K082098510(k) TraditionalCleared Aug 25, 200831-day reviewClass II21 CFR 892.1550Recalls 2

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 Aug 25, 2008 as substantially equivalent to K071134 (Sonosite,Inc., 2007) and 5 other predicates after a 31-day review. Its family tree reaches back 6 generations to 1995. 247 later devices descend from it. It has been recalled 2 times.

Decided
Aug 25, 2008
Review
31 days
Class
Class II
Product code
IYN
Recalls
2
Predicates
6

Its longest line of descent runs back 6 generations to K945773 (1995). 21 ancestors in all. 247 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 2 other ancestors2001: 2 other ancestors2003: 2 other ancestors2002: 1 other ancestor2000: 3 other ancestors1999: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor2010: 2 descendants cleared2009: 1 descendant cleared2015: 10 descendants cleared2011: 3 descendants cleared2013: 6 descendants cleared2012: 2 descendants cleared2016: 16 descendants cleared2014: 5 descendants cleared2020: 28 descendants cleared2017: 19 descendants cleared2018: 18 descendants cleared2019: 21 descendants cleared2023: 16 descendants cleared2022: 28 descendants cleared2021: 20 descendants cleared2026: 16 descendants cleared2025: 18 descendants cleared2024: 18 descendants clearedK945773 · Siemens Sonoline Versa · Siemens Medical Solutions USA, Inc. · 1995K020353 · Omnia X/XS Ultrasound System · Siemens Medical Systems, Inc. · 2002K030949 · Titan High Resolution Ultrasound System · Sonosite,Inc. · 2003K043559 · Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) · Sonosite,Inc. · 2005 · recalledK053069 · Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) · Sonosite,Inc. · 2005 · recalledK071134 · Sonosite Maxx Series Diagnostic Ultrasound System · Sonosite,Inc. · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 11 descendants3 generations forward: 23 descendants4 generations forward: 31 descendants5 generations forward: 28 descendants6 generations forward: 36 descendants7 generations forward: 35 descendants8 generations forward: 24 descendants9 generations forward: 20 descendants10 generations forward: 11 descendants11 generations forward: 7 descendants12 generations forward: 5 descendants13 generations forward: 4 descendants14 generations forward: 4 descendants15 generations forward: 1 descendant K071134 · Sonosite Maxx Series Diagnostic Ultrasound System · Sonosite,Inc. · 2007 · recalledK053069 · Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) · Sonosite,Inc. · 2005 · recalledK043559 · Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) · Sonosite,Inc. · 2005 · recalledK030949 · Titan High Resolution Ultrasound System · Sonosite,Inc. · 2003K020353 · Omnia X/XS Ultrasound System · Siemens Medical Systems, Inc. · 2002K945773 · Siemens Sonoline Versa · Siemens Medical Solutions USA, Inc. · 1995−50+5+10+15
  1. Root · 6 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
  2. 5 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
  3. 4 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
  4. 3 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  5. 2 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  6. 1 generation backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
  7. This deviceK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008
  8. Descendant · cites it directly · 216 of its ownK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
  9. Descendant · 2 generations on · 149 of its ownK133533 Logiq EGE Healthcare · 2014
  10. Descendant · 3 generations on · 131 of its ownK143452 Logiq P9, Logiq P7GE Healthcare · 2015
  11. Descendant · 4 generations on · 107 of its ownK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
  12. Descendant · 3 generations on · 60 of its ownK151028 LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2015

Showing 5 of 247 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 32012: 22013: 62014: 52015: 102016: 162017: 192018: 182019: 212020: 282021: 202022: 282023: 162024: 182025: 182026: 16
2009high 28 (2020) · low 1 (2009)2026

Most influential descendants

Showing 5 of 247 · See all
  • K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · cites it directly216descendants
  • K133533Logiq EGE Healthcare · 2014 · 2 generations on149descendants
  • K143452Logiq P9, Logiq P7GE Healthcare · 2015 · 3 generations on131descendants
  • K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 4 generations on107descendants
  • K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 3 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K945773Siemens Sonoline VersaSiemens Medical Solutions USA, Inc.1995—
−5K020353Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc.2002—
−4K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003—
−3K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20054
−2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20053
−1K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072
0 (this device)K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.2008—
+1K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20111
+2K133533Logiq EGE Healthcare2014—
+3K143452Logiq P9, Logiq P7GE Healthcare2015—
+4K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016—
+3K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199720
199910
200030
200120
200210
200320
200420
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201130
201220
201360
201450
2015100
2016160
2017190
2018180
2019210
2020280
2021200
2022280
2023160
2024180
2025180
2026160
FIG. 1 — Lineage of K082098, 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? (6)

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
*K071134Sonosite Maxx Series Diagnostic Ultrasound System
Summary page 1
…: SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite MaXXTM Series Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDI® 5000 Ultrasound System (K…
Sonosite,Inc.20072
*K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)
Summary page 1
…in this Submission is substantially equivalent to a combination of the SonoSite MaXXTM Series Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDI® 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound Syste…
Sonosite,Inc.20053
*K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)
Summary page 1
…ission is substantially equivalent to a combination of the SonoSite MaXXTM Series Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDI® 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound System (K061129).…
Sonosite,Inc.20054
*K034003Hdi 5000 Diagnostic Ultrasound System
Summary page 1
…MaXXTM Series Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDI® 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound System (K061129). 4) Device Description: The SonoSite Maxx Series Ultrasound…
Philips Ultrasound, Inc.20044
*K011224Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…
Summary page 1
…es Ultrasound System (K071134), the SonoSite MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDI® 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound System (K061129). 4) Device Description: The SonoSite Maxx Series Ultrasound System is a…
Advanced Technology Laboratories, Inc.2001—
*K061129GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000
Summary page 1
…MicroMaxx® Ultrasound System (K053069 and K043559), the Philips Medical Systems HDI® 5000 Ultrasound System (K034003 and K011224) and the GE Logiq 9 Ultrasound System (K061129). 4) Device Description: The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software con…
General Electric Co.20061

Also cleared against K071134: 5 other devices →

What descends from it? (247)

See all 247

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

NumberDeviceApplicantDecidedDescendants
K113156Sonosite Edge Ultrasound SystemSonosite,Inc.2011216
K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.201352
K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.200927
K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114
K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152
K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150
K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 18, 2011Not classifiedZ-0057-2012Software designThis is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment.
May 27, 2010Not classifiedZ-2116-2010Nonconforming Material/ComponentPowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 7 of the 21 ancestors have a recall of any class.
  • Of its descendants, K113156 (Sonosite,Inc., 2011) has gone furthest, with 216 descendants of its own.
  • 5 other devices also cite its predicate K071134.

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 device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications: Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skel. (Conventional)…

Read the full statement (138 words)

The device is intended for prescription use (Per 21 CFR 801.109) for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following clinical applications:

Ophthalmic

Fetal - OB/GYN

Abdominal

Intra-operative

(Abdominal organs and vascular)

Intra-operative (Neuro.)

Laparoscopic

Pediatric

Small Organ

(breast, thyroid, testicles, prostate)

Neonatal Cephalic

Adult Cephalic

Trans-rectal

Trans-vaginal

Musculo-skel. (Conventional)

Musculo-skel. (Superficial)

Cardiac Adult

Cardiac Pediatric

Trans-esophageal (card.)

Peripheral vessel

SiteLinkTM Image Manager is a software accessory for SonoSite Maxx Series medical diagnostic ultrasound systems. SiteLink enables image download, in full resolution .bmp format or compressed .jpg format, from SonoSite systems to a Windows-based PC.

The SonoSite® DICOM/Clips Bundle is a software option available on SonoSite Maxx SeriesTM medical diagnostic ultrasound systems. It is intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Indications for use as stated in the FDA summary.

Also cleared against K071134

5 other devices cite the same predicate.

  • K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
  • K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 20111 recall
  • K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 20101 recall
  • K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 20092 recalls

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/K082098 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082098: Sonosite Maxx Series 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/K082098

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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