510(k) · Cleared
Recalled · Class II · 2022Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical System Israel, Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 5, 2010 as substantially equivalent to K092079 (Ge Medical Systems Israel, Ultrasound, Ltd., 2009) after a 74-day review. Its family tree reaches back 4 generations to 2000. 177 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 5, 2010
- Review
- 74 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000695 (2000). 177 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
- 3 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
- 2 generations backK071985 GE Vivid S5 and S6 Diagnostic UltrasoundGeneral Electric Co. · 2007 · Recalled
- 1 generation backK092079 Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled
- This deviceK102393 Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound…Ge Medical System Israel, Ltd. · 2010
- Descendant · cites it directly · 176 of its ownK121063 Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic…Ge Medical System Israel, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 151 of its ownK141639 Voluson S6, Voluson S8GE 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
- Descendant · 2 generations on · 84 of its ownK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
Showing 5 of 177 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 177 · See all- K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2012 · cites it directly176descendants
- K141639Voluson S6, Voluson S8GE Healthcare · 2014 · 2 generations on151descendants
- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · 3 generations on131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 4 generations on107descendants
- K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 2014 · 2 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000695 | GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging… | Ge Medical Systems, Inc. | 2000 | — |
| −3 | K020789 | GE Vivid 3 Expert; GE Vivid 3 Pro | General Electric Co. | 2002 | — |
| −2 | K071985 | GE Vivid S5 and S6 Diagnostic Ultrasound | General Electric Co. | 2007 | 2 |
| −1 | K092079 | Modification to GE Vivid S5 and S6 Diagnostic Ultrasound | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009 | 2 |
| 0 (this device) | K102393 | Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System | Ge Medical System Israel, Ltd. | 2010 | — |
| +1 | K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2012 | 2 |
| +2 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| +3 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +4 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| +2 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel, Ltd. | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 14 | 0 |
| 2018 | 17 | 0 |
| 2019 | 18 | 0 |
| 2020 | 22 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 12 | 0 |
| 2024 | 16 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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? (1)
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 |
|---|---|---|---|
| * | K092079 | Modification to GE Vivid S5 and S6 Diagnostic UltrasoundSummary page 2…Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): Vivid 85 and Vivid 86 Diagnostic Ultrasound Systems, K092079 currently in commercial distribution. Device Descrip~tion:. The Vivid S5 and Vivid S6 are… | 2009 |
| † | K071985 | GE Vivid S5 and S6 Diagnostic Ultrasound | 2007 |
What descends from it? (177)
See all 1771 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System | 2012 | 176 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2022 | Class II | Z-0752-2023 | Device Design | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
| Nov 10, 2022 | Class II | Z-0753-2023 | Device Design | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K121063 (Ge Medical System Israel, Ltd., 2012) has gone furthest, with 176 descendants of its own.
- 3 other devices also cite its predicate K092079.
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. 2010, 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 current modifications do not change the indications for use. As previously reported and cleared, the Vivid S5/S6 ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and…
Read the full statement (136 words)
The current modifications do not change the indications for use. As previously reported and cleared, the Vivid S5/S6 ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Ultrasound imaging, measurement and analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102393: Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102393
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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