510(k) · Cleared
ClearedLogiq S8
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 Aug 26, 2013 as substantially equivalent to K111582 (GE Healthcare, 2011) and 3 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1995. 219 later devices descend from it.
- Decided
- Aug 26, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K935595 (1995). 120 ancestors in all, the oldest K863700 (1987). 219 later devices descend from it, 6 citing it directly.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- This deviceK131527 Logiq S8GE Healthcare · 2013
- Descendant · cites it directly · 155 of its ownK133034 Logiq F SeriesGE Healthcare · 2014
- Descendant · cites it directly · 149 of its ownK133533 Logiq EGE Healthcare · 2014
- Descendant · cites it directly · 144 of its ownK141261 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014
- Descendant · 2 generations on · 131 of its ownK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- Descendant · 3 generations on · 107 of its ownK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 4 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- This deviceK131527 Logiq S8GE Healthcare · 2013
Showing 5 of 219 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 219 · See all- K133034Logiq F SeriesGE Healthcare · 2014 · cites it directly155descendants
- K133533Logiq EGE Healthcare · 2014 · cites it directly149descendants
- K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014 · cites it directly144descendants
- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · 2 generations on131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 3 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −2 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −1 | K122114 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2012 | 1 |
| 0 (this device) | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| +1 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
| +1 | K133533 | Logiq E | GE Healthcare | 2014 | — |
| +1 | K141261 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2014 | — |
| +2 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +3 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 20 | 0 |
| 2019 | 18 | 0 |
| 2020 | 29 | 0 |
| 2021 | 18 | 0 |
| 2022 | 25 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 17 | 0 |
| 2026 | 17 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111582 | Logiq S8Summary page 1…sed Echo Imaging System, 21CFR 892.1 560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): KI 111582 LOGIQ S8 Diagnostic Ultrasound System K 123564 LOGIQ E9 Diagnostic Ultrasound System… | 2011 |
| * | K123564 | Logiq E9 Diagnostic Ultrasound SystemSummary page 1…Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): KI 111582 LOGIQ S8 Diagnostic Ultrasound System K 123564 LOGIQ E9 Diagnostic Ultrasound System K 1221 14 LOGIQ S7 Diagnostic Ultrasound System… | 2012 |
| * | K122114 | Logiq S7 Expert, Logiq S7 ProSummary page 1…e Device(s): KI 111582 LOGIQ S8 Diagnostic Ultrasound System K 123564 LOGIQ E9 Diagnostic Ultrasound System K 1221 14 LOGIQ S7 Diagnostic Ultrasound System KI 13690 LOGIQ e Diagnostic Ultrasound System… | 2012 |
| Kept off the family tree | K013690 | FDA’s K013690 is Ident-A100 Intraoral Video Camera Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemSummary page 1…K 1221 14 LOGIQ S7 Diagnostic Ultrasound System KI 13690 LOGIQ e Diagnostic Ultrasound System K101 149 Vivid E9 Diagnostic Ultrasound System 42… | 2010 |
What descends from it? (219)
See all 2196 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 18 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 35 of the 120 ancestors have a recall of any class.
- Of its descendants, K133034 (GE Healthcare, 2014) has gone furthest, with 155 descendants of its own.
- 2 other devices also cite its predicate K111582.
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. 2013, 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 Fetal; 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 Intraoperative (abdominal. thoracic, vascular and neurosurgical).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131527: Logiq S8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131527
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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