510(k) · Cleared
Recalled · Class II · 2025Venue Fit
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 Jun 10, 2024 as substantially equivalent to K220848 (GE Medical Systems, 2022) after a 167-day review. Its family tree reaches back 27 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 10, 2024
- Review
- 167 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 27 generations to K935595 (1995). 200 ancestors in all, the oldest K850478 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations between
- 3 generations backK183362 Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · Recalled
- 2 generations backK203137 Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · Recalled
- 1 generation backK220848 Venue FitGE Medical Systems · 2022 · Recalled
- This deviceK234106 Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2024
- Descendant · cites it directly · 1 of its ownK251322 Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics · 2025
- Descendant · 2 generations on · 0 of its ownK261668 Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
Show all 27 generations
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 26 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 25 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 24 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 23 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 22 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 21 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 20 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 19 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 18 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 17 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 16 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 15 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 14 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 13 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 12 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 11 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 10 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 9 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 8 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 7 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 6 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 5 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 4 generations backK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- 3 generations backK183362 Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · Recalled
- 2 generations backK203137 Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · Recalled
- 1 generation backK220848 Venue FitGE Medical Systems · 2022 · Recalled
- This deviceK234106 Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −26 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −25 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −24 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −23 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −22 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −21 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −20 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −19 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −18 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −17 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −16 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −15 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −14 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −13 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −12 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −11 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −10 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −9 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −8 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −7 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −6 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −5 | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| −4 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| −3 | K183362 | Venue GO | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | 2 |
| −2 | K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 1 |
| −1 | K220848 | Venue Fit | GE Medical Systems | 2022 | 1 |
| 0 (this device) | K234106 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024 | — |
| +1 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025 | — |
| +2 | K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K220848 | Venue FitSummary page 4…em, 21CFR 892.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: K220848 Venue Fit, Diagnostic Ultrasound System Classification Names: Class II Product Code: Ultrasonic Pulsed Dopple… | 2022 |
| † | K231301 | Vscan Air | 2023 |
| † | K161047 | LOGIQ P9 and LOGIQ P7 | 2016 |
| † | K231989 | LOGIQ E10s, LOGIQ Fortis | 2023 |
| † | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | 2018 |
| † | K202035 | Vscan Air | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | 2025 | 1 |
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-1556-2025 | Under Investigation by firm | The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 62 of the 200 ancestors have a recall of any class.
- Of its descendants, K251322 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K220848.
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. 2024, 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 Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include…
Read the full statement (185 words)
The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). 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, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234106: Venue Fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234106
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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