510(k) · Cleared
Recalled · Class II · 2022Vivid I Diagnostic Ultrasound System, Vivid Q 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. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 17, 2012 as substantially equivalent to K102388 (Ge Medical System Israel, Ltd., 2010) and 1 other predicate after a 133-day review. Its family tree reaches back 7 generations to 2001. 110 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2012
- Review
- 133 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K003931 (2001). 16 ancestors in all, the oldest K000695 (2000). 110 later devices descend from it, 3 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 deviceK121062 Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound…Ge Medical System Israel, Ltd. · 2012
- Descendant · cites it directly · 46 of its ownK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- Descendant · cites it directly · 35 of its ownK152543 M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 28 of its ownK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · cites it directly · 27 of its ownK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 2 generations on · 25 of its ownK180039 ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016 · cites it directly46descendants
- K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · cites it directly35descendants
- K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on28descendants
- K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017 · cites it directly27descendants
- K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on25descendants
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) | K121062 | Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System | Ge Medical System Israel, Ltd. | 2012 | — |
| +1 | K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016 | — |
| +1 | K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +2 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +1 | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +2 | K180039 | ACUSON P600 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 13 | 0 |
| 2021 | 10 | 0 |
| 2022 | 17 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 18 | 0 |
| 2026 | 7 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K102388 | Vivid I Diagnostic Ultrasound SystemSummary page 1…e Archiving and Communication System, 21 CER 892.2050, 90-LLZ Predicate Device(s): Vivid i and Vivid q Diagnostic Ultrasound Systems, K 102388. Vivid E9 Diagnostic Ultrasound System, K 10 1149. Device Description: The Vivid i and Vivid… | 2010 |
| * | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemSummary page 1…90-LLZ Predicate Device(s): Vivid i and Vivid q Diagnostic Ultrasound Systems, K 102388. Vivid E9 Diagnostic Ultrasound System, K 10 1149. Device Description: The Vivid i and Vivid q are mobile ultrasound consoles having a wide ass… | 2010 |
| † | K102393 | Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System | 2010 |
| † | K113690 | GE Logiq I, Logiq E and Vivid E | 2011 |
| † | K112050 | Soundstar Eco Diagnostic Ultrasound Catheter | 2011 |
What descends from it? (110)
See all 1103 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-0757-2023 | 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 1.8 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K161706 (Ge Medical Systems Ultrasound and Primary Care Diagnostics L, 2016) has gone furthest, with 46 descendants of its own.
- 2 other devices also cite its predicate K102388.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The Vivid i/q 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…
Read the full statement (122 words)
The Vivid i/q 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).
The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121062: Vivid I Diagnostic Ultrasound System, Vivid Q 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/K121062
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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