510(k) Report

510(k) · Cleared

Cleared

Sonosite Nanomaxx Series Ultrasound System

K102390510(k) TraditionalCleared Nov 19, 201088-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 Nov 19, 2010 as substantially equivalent to K092058 (Sonosite,Inc., 2009) and 2 other predicates after an 88-day review. Its family tree reaches back 8 generations to 1995.

Decided
Nov 19, 2010
Review
88 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K945773 (1995). 23 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, 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 ancestorK945773 · 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 · recalledK082098 · Sonosite Maxx Series Ultrasound System · Sonosite,Inc. · 2008 · recalledK092058 · Sonosite Nanomaxx Series Ultrasound System · Sonosite,Inc. · 2009 · recalled1995200020052010
Other ancestors, by generation 2 generations back: 3 other ancestors3 generations back: 10 other ancestors4 generations back: 2 other ancestors K092058 · Sonosite Nanomaxx Series Ultrasound System · Sonosite,Inc. · 2009 · recalledK082098 · Sonosite Maxx Series Ultrasound System · Sonosite,Inc. · 2008 · recalledK071134 · 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
  1. Root · 8 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
  2. 7 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
  3. 6 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
  4. 5 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  5. 4 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
  6. 3 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
  7. 2 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
  8. 1 generation backK092058 Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2009 · Recalled
  9. This deviceK102390 Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K945773Siemens Sonoline VersaSiemens Medical Solutions USA, Inc.1995—
−7K020353Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc.2002—
−6K030949Titan High Resolution Ultrasound SystemSonosite,Inc.2003—
−5K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20054
−4K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20053
−3K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072
−2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082
−1K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20092
0 (this device)K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199720
199910
200030
200120
200210
200320
200420
200610
FIG. 1 — Lineage of K102390, 1995–2010Source: 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
*K092058Sonosite Nanomaxx Series Ultrasound System
Summary page 1
…ally marketed device: SonoSite, Inc. believes that the system described in this submission is substantially equivalent to the SonoSite NanoMaxx Series Ultrasound System (K092058) and the Maxx Series Ultrasound System (K071134 and K082098). 4. Device Description: The SonoSite NanoMaxx Series Ultrasound Sy…
Sonosite,Inc.20092
*K071134Sonosite Maxx Series Diagnostic Ultrasound System
Summary page 1
…at the system described in this submission is substantially equivalent to the SonoSite NanoMaxx Series Ultrasound System (K092058) and the Maxx Series Ultrasound System (K071134 and K082098). 4. Device Description: The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, softwa…
Sonosite,Inc.20072
*K082098Sonosite Maxx Series Ultrasound System
Summary page 1
…m described in this submission is substantially equivalent to the SonoSite NanoMaxx Series Ultrasound System (K092058) and the Maxx Series Ultrasound System (K071134 and K082098). 4. Device Description: The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlle…
Sonosite,Inc.20082

Also cleared against K092058: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • 9 of the 23 ancestors have a recall of any class.
  • 1 other device also cites its predicate K092058.

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. 2010, 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 SonoSite NanoMaxx Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB3; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Trans-rectal; Trans-vaginal Peripheral Vessel; Intra-operative (abdominal organs, vascular); Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.

Indications for use as stated in the FDA summary.

Also cleared against K092058

1 other device cites the same predicate.

  • K101605Mylabone Ultrasound SystemEsaote Europe B.V. · 2010

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
  • K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
  • K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2010
  • K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 20092 recalls

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/K102390 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102390: Sonosite Nanomaxx Series 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/K102390

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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