510(k) · Cleared
Recalled · 2011Sonosite Maxx Series Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 8, 2007 as substantially equivalent to K043559 (Sonosite,Inc., 2005) and 3 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1995. 259 later devices descend from it. It has been recalled 2 times.
- Decided
- May 8, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 5 generations to K945773 (1995). 16 ancestors in all. 259 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 4 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 3 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 2 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 1 generation backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- This deviceK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007
- Descendant · cites it directly · 247 of its ownK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- Descendant · cites it directly · 216 of its ownK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- Descendant · 2 generations on · 149 of its ownK133533 Logiq EGE Healthcare · 2014
- Descendant · 3 generations on · 131 of its ownK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- Descendant · 4 generations on · 107 of its ownK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
Showing 5 of 259 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 259 · See all- K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · cites it directly247descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −4 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −3 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −2 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −1 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| 0 (this device) | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | — |
| +1 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| +1 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| +2 | K133533 | Logiq E | GE Healthcare | 2014 | — |
| +3 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +4 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 12 | 0 |
| 2016 | 16 | 0 |
| 2017 | 19 | 0 |
| 2018 | 19 | 0 |
| 2019 | 21 | 0 |
| 2020 | 28 | 0 |
| 2021 | 21 | 0 |
| 2022 | 28 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 20 | 0 |
| 2026 | 16 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Summary page 12…n the placement of needles and catheters in vascular or other anatomical structures was cleared in K030949. All items marked P were previously cleared in510(k) K043559. Prescription Use (Per 21 CFR 801.109) (Division~ Si n-Oft~… | 2005 |
| * | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Summary page 1…lieves that the System described in this Submission is substantially equivalent to a combination of the SonoSite MicroMaxx Series Ultrasound System jK43559 and K053069), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K034003 and… | 2005 |
| * | K034003 | Hdi 5000 Diagnostic Ultrasound SystemSummary page 1…icroMaxx Series Ultrasound System jK43559 and K053069), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K034003 and K01 1224). 510O(K) Summary Of Safety And Effectiveness… | 2004 |
| * | K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…Summary page 1…ound System jK43559 and K053069), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDI 5000 Ultrasound System (K034003 and K01 1224). 510O(K) Summary Of Safety And Effectiveness Page I Of 6… | 2001 |
| † | K030949 | Titan High Resolution Ultrasound System | 2003 |
| † | K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System… | 2003 |
What descends from it? (259)
See all 2596 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082098 | Sonosite Maxx Series Ultrasound System | 2008 | 247 |
| K113156 | Sonosite Edge Ultrasound System | 2011 | 216 |
| K092058 | Sonosite Nanomaxx Series Ultrasound System | 2009 | 27 |
| K100402 | Site-Rite Vision Ultrasound System | 2010 | 10 |
| K150148 | Terason uSmart3300 Ultrasound System | 2015 | 0 |
| K102390 | Sonosite Nanomaxx Series Ultrasound System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2011 | Not classified | Z-0057-2012 | Software design | This 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. |
| Aug 8, 2008 | Not classified | Z-2191-2010 | Other | The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K082098 (Sonosite,Inc., 2008) has gone furthest, with 247 descendants of its own.
- 4 other devices also cite its predicate K043559.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071134: Sonosite Maxx Series Diagnostic 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/K071134
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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