510(k) · Cleared
Recalled · Class II · 2022Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical System Israel, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 21, 2012 as substantially equivalent to K102393 (Ge Medical System Israel, Ltd., 2010) and 1 other predicate after a 137-day review. Its family tree reaches back 7 generations to 2001. 176 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 21, 2012
- Review
- 137 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K003931 (2001). 12 ancestors in all, the oldest K000695 (2000). 176 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 6 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 5 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
- 4 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
- 3 generations backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
- 2 generations backK081921 GE Vivid E9 UltrasoundGeneral Electric Co. · 2008
- 1 generation backK101149 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2010
- This deviceK121063 Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic…Ge Medical System Israel, Ltd. · 2012
- Descendant · cites it directly · 151 of its ownK141639 Voluson S6, Voluson S8GE 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 · cites it directly · 84 of its ownK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 73 of its ownK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015 · Recalled
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 176 · See all- K141639Voluson S6, Voluson S8GE Healthcare · 2014 · cites it directly151descendants
- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · 2 generations on131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 3 generations on107descendants
- K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 2014 · cites it directly84descendants
- K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS · 2015 · 2 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −6 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −5 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| −4 | K051449 | GE Vivid 7 with or Without Suffix | GE Medical Systems | 2005 | — |
| −3 | K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | General Electric Co. | 2006 | 1 |
| −2 | K081921 | GE Vivid E9 Ultrasound | General Electric Co. | 2008 | — |
| −1 | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2010 | — |
| 0 (this device) | K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2012 | — |
| +1 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| +2 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +3 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| +1 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel, Ltd. | 2014 | 3 |
| +2 | K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic… | Ge Vingmed Ultrasound AS | 2015 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K102393 | Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound SystemSummary page 1…Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Predicate Device(s): Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K(102393. Vivid E9 Diagnostic Ultrasound System, K101 149. Device Description: The Vivid S5 and Viv… | 2010 |
| * | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemSummary page 1…, 90-IYO Predicate Device(s): Vivid S5 and Vivid S6 Diagnostic Ultrasound Systems, K(102393. Vivid E9 Diagnostic Ultrasound System, K101 149. Device Description: The Vivid S5 and Vivid S6 are mobile ultrasound consoles having a wide… | 2010 |
| † | K071985 | GE Vivid S5 and S6 Diagnostic Ultrasound | 2007 |
| † | K092079 | Modification to GE Vivid S5 and S6 Diagnostic Ultrasound | 2009 |
| † | K082374 | Vivid I and Vivid Q | 2008 |
What descends from it? (176)
See all 1765 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 |
|---|---|---|---|---|
| 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 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K141639 (GE Healthcare, 2014) has gone furthest, with 151 descendants of its own.
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. 2012, 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 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; Transtectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121063 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121063: Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121063
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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