510(k) · Cleared
Recalled · Class II · 2013Sonosite Edge 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 Nov 15, 2011 as substantially equivalent to K071134 (Sonosite,Inc., 2007) and 1 other predicate after a 20-day review. Its family tree reaches back 7 generations to 1995. 216 later devices descend from it. It has been recalled once.
- Decided
- Nov 15, 2011
- Review
- 20 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945773 (1995). 22 ancestors in all. 216 later devices descend from it, 6 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 deviceK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011
- Descendant · cites it directly · 149 of its ownK133533 Logiq EGE Healthcare · 2014
- Descendant · 2 generations on · 131 of its ownK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- Descendant · 3 generations on · 107 of its ownK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- Descendant · 2 generations on · 60 of its ownK151028 LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
- Descendant · cites it directly · 60 of its ownK133431 VENUE 50GE Healthcare · 2013
Showing 5 of 216 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 216 · See all- K133533Logiq EGE Healthcare · 2014 · cites it directly149descendants
- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · 2 generations on131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 3 generations on107descendants
- K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 2 generations on60descendants
- K133431VENUE 50GE Healthcare · 2013 · cites it directly60descendants
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) | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | — |
| +1 | K133533 | Logiq E | GE Healthcare | 2014 | — |
| +2 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +3 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| +2 | K151028 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | — |
| +1 | K133431 | VENUE 50 | GE Healthcare | 2013 | — |
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 |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 15 | 0 |
| 2017 | 16 | 0 |
| 2018 | 17 | 0 |
| 2019 | 20 | 0 |
| 2020 | 26 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 15 | 0 |
| 2024 | 18 | 0 |
| 2025 | 15 | 0 |
| 2026 | 15 | 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? (2)
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…unications System 892.2050 LLZ 3) Identification of the predicate or legally marketed device: SonoSite Maxx Series Ultrasound System K071 134 / K082098 4) Device Description: The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpos… | 2007 |
| * | K082098 | Sonosite Maxx Series Ultrasound SystemSummary page 1…System 892.2050 LLZ 3) Identification of the predicate or legally marketed device: SonoSite Maxx Series Ultrasound System K071 134 / K082098 4) Device Description: The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnos… | 2008 |
What descends from it? (216)
See all 2166 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 |
|---|---|---|---|---|
| Sep 11, 2013 | Class II | Z-0027-2014 | Error in labeling | FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 22 ancestors have a recall of any class.
- Of its descendants, K133533 (GE Healthcare, 2014) has gone furthest, with 149 descendants of its own.
- 5 other devices also cite its predicate K071134.
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. 2011, 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?
The SonoSite Edge 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: Ophthalmic, Fetal - OB/GYN, Abdominal, Intra-operative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113156: Sonosite Edge 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/K113156
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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