510(k) · Cleared
ClearedVivid Explorer/Vivid Advanced/Vivid Focus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 2, 2026 as substantially equivalent to K223832 (Ge Medical System Ultrasound and Primary Care Diagnostics, 2023) after a 134-day review. Its family tree reaches back 28 generations to 1995.
- Decided
- Sep 2, 2026
- Review
- 134 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 28 generations to K935595 (1995). 262 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 28 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations between
- 3 generations backK211216 Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2021 · Recalled
- 2 generations backK220619 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · Recalled
- 1 generation backK223832 Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics · 2023 · Recalled
- This deviceK261313 Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
Show all 28 generations
- Root · 28 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 27 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 26 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 25 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 24 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 23 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 22 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 21 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 20 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 19 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 18 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 17 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 16 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 15 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 14 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 13 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 12 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 11 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 10 generations backK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
- 9 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
- 8 generations backK160184 Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · Recalled
- 7 generations backK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- 6 generations backK170878 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · Recalled
- 5 generations backK182450 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
- 4 generations backK200497 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · Recalled
- 3 generations backK211216 Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2021 · Recalled
- 2 generations backK220619 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · Recalled
- 1 generation backK223832 Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics · 2023 · Recalled
- This deviceK261313 Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −27 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −26 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −25 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −24 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −23 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −22 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −21 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −20 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −19 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −18 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −17 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −16 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −15 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −14 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −13 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −12 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −11 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −10 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | — |
| −9 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015 | — |
| −8 | K160184 | Voluson S6, Voluson S8, Voluson S10 | GE Healthcare | 2016 | 1 |
| −7 | K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016 | — |
| −6 | K170878 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | 2 |
| −5 | K182450 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 2 |
| −4 | K200497 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 2 |
| −3 | K211216 | Vivid S60N / Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021 | 2 |
| −2 | K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | 2 |
| −1 | K223832 | Vivid S60N, Vivid S70N | Ge Medical System Ultrasound and Primary Care Diagnostics | 2023 | 2 |
| 0 (this device) | K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 13 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 15 | 0 |
| 2007 | 12 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 13 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 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? (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 |
|---|---|---|---|
| * | K223832 | Vivid S60N, Vivid S70NSummary page 6…570, 90-ITX Medical image management and processing system, 21 CFR 892.2050, 90-QIH Primary Predicate Device: K223832 Vivid S70N/S60N Reference Device(s): K251169 Vivid Pioneer K243628… | 2023 |
| † | K251169 | Vivid Pioneer | 2025 |
| † | K243628 | Vivid T9/Vivid T8 | 2025 |
| † | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | 2024 |
| † | K243620 | Vivid iq | 2025 |
| † | K170823 | Vivid E80, Vivid E90, Vivid E95 | 2017 |
| † | K181685 | Vivid E80, Vivid E90, Vivid E95 | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 76 of the 262 ancestors have a recall of any class.
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. 2026, 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?
Vivid Explorer, Vivid Advanced and Vivid Focus are general-purpose ultrasound systems, specialized for use in cardiac imaging. They are intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid Explorer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a…
Read the full statement (519 words)
Vivid Explorer, Vivid Advanced and Vivid Focus are general-purpose ultrasound systems, specialized for use in cardiac imaging. They are intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid Explorer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/ 4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Vivid Advanced is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Vivid Focus is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room and Cath lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
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/K261313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261313: Vivid Explorer/Vivid Advanced/Vivid Focus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261313
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026