510(k) · Cleared
ClearedLOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
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 Mar 25, 2016 as substantially equivalent to K133034 (GE Healthcare, 2014) and 4 other predicates after a 52-day review. Its family tree reaches back 19 generations to 1995. 47 later devices descend from it.
- Decided
- Mar 25, 2016
- Review
- 52 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K935595 (1995). 149 ancestors in all, the oldest K850478 (1985). 47 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- 2 generations backK133034 Logiq F SeriesGE Healthcare · 2014
- 1 generation backK141768 Logiq V5/Logiq V3GE Healthcare · 2014
- This deviceK160277 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
- Descendant · cites it directly · 46 of its ownK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- Descendant · 2 generations on · 28 of its ownK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 3 generations on · 14 of its ownK183362 Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · Recalled
- Descendant · 2 generations on · 10 of its ownK170878 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · Recalled
- Descendant · 2 generations on · 9 of its ownK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 10 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 9 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 7 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 6 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 5 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 4 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 3 generations backK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- 2 generations backK133034 Logiq F SeriesGE Healthcare · 2014
- 1 generation backK141768 Logiq V5/Logiq V3GE Healthcare · 2014
- This deviceK160277 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016 · cites it directly46descendants
- K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on28descendants
- K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · 3 generations on14descendants
- K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · 2 generations on10descendants
- K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −10 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −9 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −7 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −6 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −5 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −4 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −3 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
| −2 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
| −1 | K141768 | Logiq V5/Logiq V3 | GE Healthcare | 2014 | — |
| 0 (this device) | K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016 | — |
| +1 | K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016 | — |
| +2 | 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 | K170878 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | 2 |
| +2 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
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 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 13 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 9 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K133034 | Logiq F SeriesSummary page 17…o Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): LOGIQ F Series - K133034 LOGIQ S7 – K141261Venue 50 - K152758 LOGIQ V3 / LOGIQ V5 -K141768… | 2014 |
| * | K141261 | Logiq S7 Expert, Logiq S7 ProSummary page 6…y cleared by FDA 133034; P2= previously cleared by FDA K141768; P3= previously cleared by FDA K151028; P4=previously cleared by FDA K152758; P5=previously cleared by FDA K141261 Notes: [1] Abdominal includes GYN and Urological/Prostate; [2] Small Organ includes breast, testes, thyroid;… | 2014 |
| * | K152758 | Venue 50Summary page 6…Block N = new indication; P= previously cleared by FDA 133034; P2= previously cleared by FDA K141768; P3= previously cleared by FDA K151028; P4=previously cleared by FDA K152758; P5=previously cleared by FDA K141261 Notes: [1] Abdominal includes GYN and Urological/Prostate; [2] Small Organ incl… | 2015 |
| * | K141768 | Logiq V5/Logiq V3Summary page 6…P P P [5] Vascular Access (IV, PICC) Nerve Block N = new indication; P= previously cleared by FDA 133034; P2= previously cleared by FDA K141768; P3= previously cleared by FDA K151028; P4=previously cleared by FDA K152758; P5=previously cleared by FDA K141261 Notes: [1]… | 2014 |
| * | K151028 | LOGIQ eSummary page 6…5] Vascular Access (IV, PICC) Nerve Block N = new indication; P= previously cleared by FDA 133034; P2= previously cleared by FDA K141768; P3= previously cleared by FDA K151028; P4=previously cleared by FDA K152758; P5=previously cleared by FDA K141261 Notes: [1] Abdominal includes GYN and Urological/P… | 2015 |
What descends from it? (47)
See all 472 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 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 39 of the 149 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.
- 4 other devices also cite its predicate K133034.
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. 2016, 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 LOGIQ F8 Expert / LOGIQ F8 / LOGIQ F6 are general purpose ultrasound imaging and analysis systems providing digital acquisition, processing and display capability, clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Transcranial, Pediatric, Musculoskeletal, Urological, Cardiac, Transvaginal, Transrectal, and Biopsy.
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/K160277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160277: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160277
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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