510(k) · Cleared
Recalled · 2010Sonosite Nanomaxx Series Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 2, 2009 as substantially equivalent to K071134 (Sonosite,Inc., 2007) and 3 other predicates after an 86-day review. Its family tree reaches back 7 generations to 1995. 27 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 2, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 7 generations to K945773 (1995). 22 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 6 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 5 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 4 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 3 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 2 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 1 generation backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- This deviceK092058 Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc. · 2009
- Descendant · cites it directly · 25 of its ownK101605 Mylabone Ultrasound SystemEsaote Europe B.V. · 2010
- Descendant · 2 generations on · 24 of its ownK111302 Mylabseven, MylabalphaEsaote, S.p.A. · 2011
- Descendant · 3 generations on · 22 of its ownK132466 Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013
- Descendant · 3 generations on · 22 of its ownK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- Descendant · 3 generations on · 19 of its ownK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K101605Mylabone Ultrasound SystemEsaote Europe B.V. · 2010 · cites it directly25descendants
- K111302Mylabseven, MylabalphaEsaote, S.p.A. · 2011 · 2 generations on24descendants
- K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013 · 3 generations on22descendants
- K132231Mylabseven, MylabalphaEsaote, S.p.A. · 2013 · 3 generations on22descendants
- K142008Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −6 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −5 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −4 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −3 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −2 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −1 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| 0 (this device) | K092058 | Sonosite Nanomaxx Series Ultrasound System | Sonosite,Inc. | 2009 | — |
| +1 | K101605 | Mylabone Ultrasound System | Esaote Europe B.V. | 2010 | — |
| +2 | K111302 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2011 | — |
| +3 | K132466 | Mylabseven 6400, Mylabalpha 7400 | Esaote, S.p.A. | 2013 | — |
| +3 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| +3 | K142008 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071134 | Sonosite Maxx Series Diagnostic Ultrasound SystemSummary page 1…device: SonoSite, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071 134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDIO 5000 Ultrasound System (K034003 an… | 2007 |
| * | K082098 | Sonosite Maxx Series Ultrasound SystemSummary page 1…Site, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite Maxx Series Ultrasound System (K071 134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDIO 5000 Ultrasound System (K034003 and K01 1224).… | 2008 |
| * | K034003 | Hdi 5000 Diagnostic Ultrasound SystemSummary page 1…e SonoSite Maxx Series Ultrasound System (K071 134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDIO 5000 Ultrasound System (K034003 and K01 1224). 4) Device Description: The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, softw… | 2004 |
| * | K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…Summary page 1…axx Series Ultrasound System (K071 134 and K082098), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDIO 5000 Ultrasound System (K034003 and K01 1224). 4) Device Description: The SonoSite NanoMaxx Series Ultrasound System is a full featured, general purpose, software controlle… | 2001 |
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2010 | Not classified | Z-0478-2011 | Software design | Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect. |
| May 27, 2010 | Not classified | Z-2116-2010 | Nonconforming Material/Component | PowerPark 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 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 22 ancestors have a recall of any class.
- Of its descendants, K101605 (Esaote Europe B.V., 2010) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K071134.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (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/OB; Abdominal; Pediatric; Small Organ (breast, thyroid, testicles,
prostate); Peripheral Vessel; Intra-operative (abdominal organs, vascular);
Musculoskeletal Conventional & Superficial, Cardiac Adult and Pediatric.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092058: Sonosite Nanomaxx Series Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092058
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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