510(k) · Cleared
Recalled · Class II · 2018GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4
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 Nov 17, 2009 as substantially equivalent to K082185 (Ge Medical Systems Ultrasound and Primary Care Dia, 2008) and 2 other predicates after a 112-day review. Its family tree reaches back 12 generations to 1995. 569 later devices descend from it. It has been recalled once.
- Decided
- Nov 17, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 12 generations to K935595 (1995). 95 ancestors in all, the oldest K891689 (1989). 569 later devices descend from it, 10 citing it directly.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- This deviceK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009
- Descendant · cites it directly · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 2 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- Descendant · cites it directly · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
- Descendant · 2 generations on · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · cites it directly · 323 of its ownK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 3 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 2 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 1 generation backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- This deviceK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009
Showing 5 of 569 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 569 · See all- K110943Logiq E9GE Healthcare · 2011 · cites it directly472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 2 generations on469descendants
- K111582Logiq S8GE Healthcare · 2011 · cites it directly367descendants
- K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 2 generations on365descendants
- K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · cites it directly323descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −3 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −2 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −1 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| 0 (this device) | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | — |
| +1 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +2 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| +1 | K111582 | Logiq S8 | GE Healthcare | 2011 | 3 |
| +2 | K122327 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +1 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 9 | 0 |
| 2012 | 19 | 0 |
| 2013 | 19 | 0 |
| 2014 | 32 | 0 |
| 2015 | 29 | 0 |
| 2016 | 37 | 0 |
| 2017 | 48 | 0 |
| 2018 | 48 | 0 |
| 2019 | 35 | 0 |
| 2020 | 51 | 0 |
| 2021 | 38 | 0 |
| 2022 | 42 | 0 |
| 2023 | 38 | 0 |
| 2024 | 45 | 0 |
| 2025 | 46 | 0 |
| 2026 | 31 | 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 |
|---|---|---|---|
| * | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Summary page 1…90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Classification: Class II Predicate Device(s): K082185 GE LOGIQ E9 Diagnostic Ultrasound System K081921 GE Vivid E9 Diagnostic Ultrasound System… | 2008 |
| * | K081921 | GE Vivid E9 UltrasoundSummary page 1…892.1570, 90-ITX Classification: Class II Predicate Device(s): K082185 GE LOGIQ E9 Diagnostic Ultrasound System K081921 GE Vivid E9 Diagnostic Ultrasound System K083095 SonixTouch Ultrasound Scanner Device Desc… | 2008 |
| * | K083095 | Sonixtouch Ultrasound SystemSummary page 1…ce(s): K082185 GE LOGIQ E9 Diagnostic Ultrasound System K081921 GE Vivid E9 Diagnostic Ultrasound System K083095 SonixTouch Ultrasound Scanner Device Description: The LOGIQ E9 is a full featured, general purpose diagnostic ultraso… | 2008 |
What descends from it? (569)
See all 56910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110943 | Logiq E9 | 2011 | 472 |
| K111582 | Logiq S8 | 2011 | 367 |
| K123564 | Logiq E9 Diagnostic Ultrasound System | 2012 | 323 |
| K103649 | Voluson S6, Voluson S8 | 2011 | 296 |
| K101874 | GE Logiq P6/P6 Pro | 2010 | 221 |
| K122114 | Logiq S7 Expert, Logiq S7 Pro | 2012 | 220 |
| K103677 | M7/M7T Diagnostic Ultrasound System | 2011 | 123 |
| K110870 | Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic… | 2011 | 89 |
| K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | 2014 | 39 |
| K101878 | GE Logiq P5 Model H44662LD | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2018 | Class II | Z-2983-2018 | Component design/selection | The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 24 of the 95 ancestors have a recall of any class.
- Of its descendants, K110943 (GE Healthcare, 2011) has gone furthest, with 472 descendants of its own.
- 7 other devices also cite its predicate K082185.
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. 2009, 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 Introoperative (abdominal, thoracic, vascular and neurosurgical).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092271
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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