510(k) · Cleared
Recalled · Class II · 2019LOGIQ E9, LOGIQ E9 XDClear 2.0
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 Sep 14, 2015 as substantially equivalent to K142160 (GE Healthcare, 2014) and 2 other predicates after a 31-day review. Its family tree reaches back 17 generations to 1995. 100 later devices descend from it. It has been recalled once.
- Decided
- Sep 14, 2015
- Review
- 31 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 17 generations to K935595 (1995). 149 ancestors in all, the oldest K863700 (1987). 100 later devices descend from it, 4 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 backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 1 generation backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- This deviceK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
- Descendant · cites it directly · 73 of its ownK163077 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
- Descendant · cites it directly · 41 of its ownK162269 Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2016
- Descendant · 2 generations on · 38 of its ownK173555 Logiq E10GE Healthcare · 2017 · Recalled
- Descendant · 2 generations on · 35 of its ownK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
- Descendant · 2 generations on · 21 of its ownK173090 Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018
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 backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 1 generation backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- This deviceK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · cites it directly73descendants
- K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2016 · cites it directly41descendants
- K173555Logiq E10GE Healthcare · 2017 · 2 generations on38descendants
- K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · 2 generations on35descendants
- K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation · 2018 · 2 generations on21descendants
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 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −1 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| 0 (this device) | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | — |
| +1 | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016 | — |
| +1 | K162269 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | 2016 | — |
| +2 | K173555 | Logiq E10 | GE Healthcare | 2017 | 2 |
| +2 | K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | 3 |
| +2 | K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Toshibamedical Systems Corporation | 2018 | — |
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 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 8 | 0 |
| 2020 | 15 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 9 | 0 |
| 2024 | 6 | 0 |
| 2025 | 13 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K142160 | Logiq E9 Diagnostic Ultrasound SystemSummary page 39…c Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Product Code: Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K142160 GE LOGIQ E9 Diagnostic Ultrasound System K131527 GE LOGIQ S8 Diagnostic Ultrasound System… | 2014 |
| * | K131527 | Logiq S8Summary page 38…ve Intraoperative Neurological Intravascular Laparoscopic N = new indication; P = previously cleared; E = added via Appendix E- previously cleared by FDA on LOGIQ S8 K131527 Notes: [1] Abdominal includes Renal, GYN/Pelvic. [2] Small organ includes breast, testes and thyroid… | 2013 |
| * | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemSummary page 39…evice(s): K142160 GE LOGIQ E9 Diagnostic Ultrasound System K131527 GE LOGIQ S8 Diagnostic Ultrasound System K131514 GE Vivid E9 Diagnostic Ultrasound System Device Description: The LOGIQ E9 is a full featured, general purpose diagnostic… | 2013 |
What descends from it? (100)
See all 1004 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 20 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 48 of the 149 ancestors have a recall of any class.
- Of its descendants, K163077 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2016) has gone furthest, with 73 descendants of its own.
- 9 other devices also cite its predicate K142160.
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. 2015, 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 and vascular).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152309
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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