510(k) · Cleared
Recalled · Class II · 2019LOGIQ S7 Expert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 26, 2016 as substantially equivalent to K141261 (GE Healthcare, 2014) and 3 other predicates after a 30-day review. Its family tree reaches back 21 generations to 1995. 36 later devices descend from it. It has been recalled once.
- Decided
- Feb 26, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 21 generations to K935595 (1995). 170 ancestors in all, the oldest K863700 (1987). 36 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations between
- 3 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 2 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 1 generation backK152195 Logiq S8GE Healthcare · 2015
- This deviceK160182 LOGIQ S7 ExpertGE Healthcare · 2016
- Descendant · cites it directly · 34 of its ownK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- Descendant · 2 generations on · 31 of its ownK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- Descendant · 3 generations on · 21 of its ownK192903 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- Descendant · 4 generations on · 13 of its ownK211945 V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
- Descendant · 5 generations on · 12 of its ownK220975 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022
Show all 21 generations
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 19 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 18 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 17 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 16 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 12 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 11 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 10 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 9 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 8 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 7 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 6 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 5 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 4 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 3 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 2 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 1 generation backK152195 Logiq S8GE Healthcare · 2015
- This deviceK160182 LOGIQ S7 ExpertGE Healthcare · 2016
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · cites it directly34descendants
- K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 2 generations on31descendants
- K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020 · 3 generations on21descendants
- K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021 · 4 generations on13descendants
- K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −20 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −19 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −18 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −17 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −16 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −15 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −12 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −11 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −10 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −9 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −8 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −7 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −6 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −5 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −4 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −3 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −2 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −1 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
| 0 (this device) | K160182 | LOGIQ S7 Expert | GE Healthcare | 2016 | — |
| +1 | K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| +2 | K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| +3 | K192903 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | — |
| +4 | K211945 | V8 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
| +5 | K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 11 | 0 |
| 2003 | 14 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 9 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K141261 | Logiq S7 Expert, Logiq S7 ProSummary page 4…LOGIQ S7 Expert system and for all of its probe/mode combinations. Combinations identified by “P” represent those previously cleared with the unmodified LOGIQ S7 Expert (K141261) or on another GE ultrasound system in the case of the probes. “N” is new in this submission. The subject modification does not a… | 2014 |
| * | K152195 | Logiq S8Summary page 26…Transvaginal Transurethral Intraoperative[8] Intraoperative Neurological Intravascular Laparoscopic N = new indication; P* = previously cleared by FDA on LOGIQ S8 K152195) Notes: [1] Abdominal includes Renal, GYN/Pelvic. [2] Small organ includes breast, testes and thyroid… | 2015 |
| * | K141639 | Voluson S6, Voluson S8Summary page 31…ate Device(s): K141261 LOGIQ S7 Expert Diagnostic Ultrasound System K152195 LOGIQ S8 Diagnostic Ultrasound System K141639 Voluson S8 Diagnostic Ultrasound System K143452 Logiq P9 Diagnostic Ultrasound System Device De… | 2014 |
| * | K143452 | Logiq P9, Logiq P7Summary page 31…K152195 LOGIQ S8 Diagnostic Ultrasound System K141639 Voluson S8 Diagnostic Ultrasound System K143452 Logiq P9 Diagnostic Ultrasound System Device Description: The LOGIQ S7 Expert is a full featured, general purpose… | 2015 |
What descends from it? (36)
See all 362 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 |
|---|---|---|---|---|
| Jul 2, 2019 | Class II | Z-1964-2019 | Device Design | Potential for a transducer mis-alignment in certain transvaginal probes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 54 of the 170 ancestors have a recall of any class.
- Of its descendants, K180409 (Samsung Medison Co., Ltd., 2018) has gone furthest, with 34 descendants of its own.
- 4 other devices also cite its predicate K141261.
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 device is intended for use by a qualified physician for ultrasound evaluation of Obstetrics (Fetal); Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160182: LOGIQ S7 Expert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160182
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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