510(k) · Cleared
ClearedLogiq S7 Expert, Logiq S7 Pro
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 Jun 5, 2014 as substantially equivalent to K122114 (GE Healthcare, 2012) and 2 other predicates after a 21-day review. Its family tree reaches back 17 generations to 1995. 144 later devices descend from it.
- Decided
- Jun 5, 2014
- Review
- 21 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K935595 (1995). 121 ancestors in all, the oldest K863700 (1987). 144 later devices descend from it, 5 citing it directly.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 2 generations backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- 1 generation backK131527 Logiq S8GE Healthcare · 2013
- This deviceK141261 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014
- Descendant · cites it directly · 131 of its ownK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- Descendant · 2 generations on · 107 of its ownK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- Descendant · 3 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · cites it directly · 57 of its ownK152195 Logiq S8GE Healthcare · 2015
- Descendant · 3 generations on · 47 of its ownK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 13 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 11 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 8 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 7 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 6 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 5 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 4 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 3 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 2 generations backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- 1 generation backK131527 Logiq S8GE Healthcare · 2013
- This deviceK141261 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014
Showing 5 of 144 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 144 · See all- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · cites it directly131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 2 generations on107descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on58descendants
- K152195Logiq S8GE Healthcare · 2015 · cites it directly57descendants
- K163596LOGIQ P9 and LOGIQ P7GE Healthcare · 2017 · 3 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −13 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −11 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −8 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −7 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −6 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −5 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −4 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −3 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −2 | K122114 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2012 | 1 |
| −1 | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| 0 (this device) | K141261 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2014 | — |
| +1 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +2 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| +3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +1 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
| +3 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
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 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 20 | 0 |
| 2023 | 11 | 0 |
| 2024 | 14 | 0 |
| 2025 | 9 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K122114 | Logiq S7 Expert, Logiq S7 ProSummary page 1…ulsed Echo Imaging System, 2I1CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892,1570, 90-ITX Predicate Device(s): K 1221 14 LOGIQ S7 Expert and LOGIQ S7 Pro Diagnostic Ultrasound Systems K 1315… | 2012 |
| * | K131527 | Logiq S8Summary page 1…0-ITX Predicate Device(s): K 1221 14 LOGIQ S7 Expert and LOGIQ S7 Pro Diagnostic Ultrasound Systems K 131527 LOGIQ S8 Diagnostic Ultrasound System K 101874 LOGIQ P6 Diagnostic Ultrasound System Devic… | 2013 |
| * | K101874 | GE Logiq P6/P6 ProSummary page 1…ro Diagnostic Ultrasound Systems K 131527 LOGIQ S8 Diagnostic Ultrasound System K 101874 LOGIQ P6 Diagnostic Ultrasound System Device Description: The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured,… | 2010 |
What descends from it? (144)
See all 1445 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 19 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 35 of the 121 ancestors have a recall of any class.
- Of its descendants, K143452 (GE Healthcare, 2015) has gone furthest, with 131 descendants of its own.
- 1 other device also cites its predicate K122114.
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. 2014, 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 Petal; Abdominal; 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 lntraoperative (abdominal. thoracic, vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141261: Logiq S7 Expert, Logiq S7 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141261
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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