510(k) · Cleared
ClearedVenue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 21, 2017 as substantially equivalent to K152758 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2015) and 3 other predicates after a 104-day review. Its family tree reaches back 22 generations to 1995. 35 later devices descend from it.
- Decided
- Jun 21, 2017
- Review
- 104 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 22 generations to K935595 (1995). 172 ancestors in all, the oldest K850478 (1985). 35 later devices descend from it, 2 citing it directly.
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations between
- 3 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 2 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 1 generation backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- This deviceK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- Descendant · cites it directly · 28 of its ownK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 2 generations on · 14 of its ownK183362 Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · Recalled
- Descendant · 2 generations on · 9 of its ownK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 2 generations on · 7 of its ownK202132 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · 3 generations on · 5 of its ownK203137 Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · Recalled
Show all 22 generations
- Root · 22 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 20 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 19 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 18 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 17 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 16 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 15 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 13 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 12 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 11 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 10 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 9 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 8 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 7 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 6 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 5 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 4 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 3 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 2 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 1 generation backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- This deviceK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · cites it directly28descendants
- K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · 2 generations on14descendants
- K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on9descendants
- K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 2 generations on7descendants
- K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −21 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −20 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −19 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −18 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −17 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −16 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −15 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −13 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −12 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −11 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −10 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −9 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −8 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −7 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −6 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −5 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −4 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −3 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −2 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −1 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| 0 (this device) | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| +1 | K180599 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +2 | K183362 | Venue GO | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | 2 |
| +2 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +2 | K202132 | Venue | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +3 | K203137 | Venue Fit | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | 1 |
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 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K152758 | Venue 50Summary page 13…2.1560, 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: Venue 50 (K152758) Secondary Predicate LOGIQ e (K151028) Device(s): Vivid S60/S70 (K142323) L… | 2015 |
| * | K151028 | LOGIQ eSummary page 5…,7,9 Nonvascular [5] N N N N N N N N N 6,7,9 N = new indication; P = previously cleared by FDA K151028; P1 = previously cleared by FDA K163596; Notes: [1] Abdominal includes GYN and Urology (includes prostate); [2] Small Org… | 2015 |
| * | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemSummary page 13…90-ITX Primary Predicate Device: Venue 50 (K152758) Secondary Predicate LOGIQ e (K151028) Device(s): Vivid S60/S70 (K142323) LOGIQ P9 and LOGIQ P7 (K163596) Device Description: The proposed Venue system is a general… | 2014 |
| * | K163596 | LOGIQ P9 and LOGIQ P7Summary page 5…N N N N N N N N 6,7,9 N = new indication; P = previously cleared by FDA K151028; P1 = previously cleared by FDA K163596; Notes: [1] Abdominal includes GYN and Urology (includes prostate); [2] Small Organ includes breast, testes, thyroid;… | 2017 |
What descends from it? (35)
See all 352 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)
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 22 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 51 of the 172 ancestors have a recall of any class.
- Of its descendants, K180599 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2018) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K152758.
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. 2017, 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 is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of-care areas in offices, clinical and hospital settings for diagnosis of patients. The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications…
Read the full statement (150 words)
The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Venue can be used include critical care and emergency room environments, as well as point-of-care areas in offices, clinical and hospital settings for diagnosis of patients.
The Venue is intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, and imaging guidance of interventional procedures (e.g. Nerve block, vascular access).
When Pinpoint GT Technology, from C.R. Bard, Inc., is included with the system, the Indications for Use include:
Pinpoint GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.
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/K170714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170714: Venue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170714
Report an extraction error
Are you the manufacturer?
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