510(k) · Cleared
Recalled · Class II · 2025Venue GO
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 Jan 28, 2019 as substantially equivalent to K180599 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2018) and 2 other predicates after a 55-day review. Its family tree reaches back 24 generations to 1995. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 28, 2019
- Review
- 55 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 24 generations to K935595 (1995). 197 ancestors in all, the oldest K850478 (1985). 14 later devices descend from it, 4 citing it directly.
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations between
- 3 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 2 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 1 generation backK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- This deviceK183362 Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
- Descendant · cites it directly · 5 of its ownK203137 Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · Recalled
- Descendant · 2 generations on · 4 of its ownK220848 Venue FitGE Medical Systems · 2022 · Recalled
- Descendant · cites it directly · 4 of its ownK202233 Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK220800 Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · Recalled
- Descendant · cites it directly · 3 of its ownK191792 Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
Show all 24 generations
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 22 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 21 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 20 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 19 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 18 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 15 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 14 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 13 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 12 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 11 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 10 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 9 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 8 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 7 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 6 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 5 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 4 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 3 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 2 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 1 generation backK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- This deviceK183362 Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · cites it directly5descendants
- K220848Venue FitGE Medical Systems · 2022 · 2 generations on4descendants
- K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · cites it directly4descendants
- K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · 2 generations on3descendants
- K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −23 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −22 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −21 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −20 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −19 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −18 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −15 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −14 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −13 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −12 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −11 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −10 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −9 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −8 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −7 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −6 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −5 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −4 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −3 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −2 | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| −1 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| 0 (this device) | K183362 | Venue GO | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | — |
| +1 | K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 1 |
| +2 | K220848 | Venue Fit | GE Medical Systems | 2022 | 1 |
| +1 | K202233 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 2 |
| +2 | K220800 | Venue Go | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | 2 |
| +1 | K191792 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 15 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 6 | 0 |
| 2012 | 11 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K180599 | VenueSummary page 6…ageal Transrectal Transvaginal Intraoperative ¥ Interventional Guidance Vascular Access (IV, PICC) Nonvascular ! N = new indication; P = previously cleared by FDA K180599; P" = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028; Notes: [1] Abdominal includes GYN and Urology… | 2018 |
| * | K151028 | LOGIQ eSummary page 6…ular Access (IV, PICC) Nonvascular ! N = new indication; P = previously cleared by FDA K180599; P" = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028; Notes: [1] Abdominal includes GYN and Urology (includes prostate); [2] Small Organ includes breast, testes, thyroid; [3] Includ… | 2015 |
| * | K181783 | Logiq P9; Logiq P7Summary page 6…perative ¥ Interventional Guidance Vascular Access (IV, PICC) Nonvascular ! N = new indication; P = previously cleared by FDA K180599; P" = previously cleared by FDA K181783; P2 = previously cleared by FDA K151028; Notes: [1] Abdominal includes GYN and Urology (includes prostate); [2] Small Organ inc… | 2018 |
What descends from it? (14)
See all 144 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 |
|---|---|---|---|---|
| Mar 6, 2025 | Class II | Z-1555-2025 | Under Investigation by firm | The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
| Sep 6, 2023 | Class II | Z-2652-2023 | Device Design | Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 59 of the 197 ancestors have a recall of any class.
- Of its descendants, K203137 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2020) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K180599.
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. 2019, 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?
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Pediatric, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access).
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/K183362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183362: Venue GO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183362
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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