510(k) · Cleared
Recalled · Class II · 2025Logiq P10, Logiq P9, Logiq P8
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 Mar 22, 2022 as substantially equivalent to K203114 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2021) after an 89-day review. Its family tree reaches back 24 generations to 1995. It has been recalled 3 times.
- Decided
- Mar 22, 2022
- Review
- 89 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 24 generations to K935595 (1995). 149 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations between
- 3 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 2 generations backK181783 Logiq P9; Logiq P7GE Healthcare · 2018 · Recalled
- 1 generation backK203114 Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics · 2021
- This deviceK214039 Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
Show all 24 generations
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 22 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 21 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 20 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 19 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 18 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 15 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 14 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 13 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 12 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 11 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 10 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 9 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 8 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 7 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 6 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 5 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 4 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 3 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 2 generations backK181783 Logiq P9; Logiq P7GE Healthcare · 2018 · Recalled
- 1 generation backK203114 Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics · 2021
- This deviceK214039 Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −23 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −22 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −21 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −20 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −19 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −18 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −15 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −14 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −13 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −12 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −11 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −10 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −9 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −8 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −7 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −6 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −5 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −4 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −3 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −2 | K181783 | Logiq P9; Logiq P7 | GE Healthcare | 2018 | 1 |
| −1 | K203114 | Logiq P10, Logiq P9, Logiq P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021 | — |
| 0 (this device) | K214039 | Logiq P10, Logiq P9, Logiq P8 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | — |
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 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 11 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K203114 | Logiq P10, Logiq P9, Logiq P8Summary page 4…ic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: K203114 LOGIQ P10/P9/P8 Diagnostic Ultrasound System Classification Names: Class ll; IYN(primary), IYO, ITX(secondary)… | 2021 |
| † | K210438 | Versana Premier | 2021 |
| † | K190442 | Koios DS for Breast | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2025 | Class II | Z-0155-2026 | Software design | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
| Sep 18, 2025 | Class II | Z-0157-2026 | Software design | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
| Sep 18, 2025 | Class II | Z-0156-2026 | Software design | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 44 of the 149 ancestors have a recall of any class.
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. 2022, 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 P8/P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; 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, Vascular). Modes of operation include: B, M, PW…
Read the full statement (95 words)
The LOGIQ P8/P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; 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, Vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The LOGIQ P8/P9/P10 is intended to be used in a hospital or medical clinic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214039: Logiq P10, Logiq P9, Logiq P8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214039
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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