510(k) · Cleared
ClearedLogiq E
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 12, 2014 as substantially equivalent to K113690 (GE Healthcare, 2011) and 3 other predicates after an 86-day review. Its family tree reaches back 17 generations to 1995. 149 later devices descend from it.
- Decided
- Feb 12, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K935595 (1995). 131 ancestors in all, the oldest K863700 (1987). 149 later devices descend from it, 2 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 deviceK133533 Logiq EGE 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 · cites it directly · 60 of its ownK151028 LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
- Descendant · 3 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 2 generations on · 57 of its ownK152195 Logiq S8GE Healthcare · 2015
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 deviceK133533 Logiq EGE Healthcare · 2014
Showing 5 of 149 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 149 · See all- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · cites it directly131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 2 generations on107descendants
- K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · cites it directly60descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on58descendants
- K152195Logiq S8GE Healthcare · 2015 · 2 generations on57descendants
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) | K133533 | Logiq E | GE Healthcare | 2014 | — |
| +1 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +2 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| +1 | K151028 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | — |
| +3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
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 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 11 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 21 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 9 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K113690 | GE Logiq I, Logiq E and Vivid ESummary page 1…tem, 2I1CF-R 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): LOGIQ i/e. Vivid e - K 113690 LOGIQ S8 - K131527 SonoSite Edge - KI 113156… | 2011 |
| * | K131527 | Logiq S8Summary page 1…Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): LOGIQ i/e. Vivid e - K 113690 LOGIQ S8 - K131527 SonoSite Edge - KI 113156 VoIlson S6/S8 - K 120741 Devce… | 2013 |
| * | K113156 | Sonosite Edge Ultrasound SystemSummary page 2…se with the exception of Ophthalmic which is substantially equivalent to Ophthalmic on the SonoSite Edge (K 113 156) and the transesophageal application has been removed from the ne… | 2011 |
| * | K120741 | Voluson S6, Voluson S8Summary page 1…Vivid e - K 113690 LOGIQ S8 - K131527 SonoSite Edge - KI 113156 VoIlson S6/S8 - K 120741 DevceDecritin:The LOGIQ e device is a laptop ultrasound console approximately 70… | 2012 |
What descends from it? (149)
See all 1492 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.
- 39 of the 131 ancestors have a recall of any class.
- Of its descendants, K143452 (GE Healthcare, 2015) has gone furthest, with 131 descendants of its own.
- 11 other devices also cite its predicate K113690.
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 LOGIQ e is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Ophthalmic; Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve Block; Vascular Access).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133533: Logiq E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133533
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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