510(k) · Cleared
ClearedGE Logiq P6/P6 Pro
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 Oct 5, 2010 as substantially equivalent to K073297 (General Electric Co., 2007) and 1 other predicate after a 95-day review. Its family tree reaches back 13 generations to 1995. 221 later devices descend from it.
- Decided
- Oct 5, 2010
- Review
- 95 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K935595 (1995). 97 ancestors in all, the oldest K891689 (1989). 221 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 1 generation backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- This deviceK101874 GE Logiq P6/P6 ProGE Healthcare · 2010
- Descendant · cites it directly · 220 of its ownK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- Descendant · 2 generations on · 219 of its ownK131527 Logiq S8GE Healthcare · 2013
- Descendant · 3 generations on · 155 of its ownK133034 Logiq F SeriesGE Healthcare · 2014
- Descendant · 3 generations on · 149 of its ownK133533 Logiq EGE Healthcare · 2014
- Descendant · cites it directly · 144 of its ownK141261 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 4 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 3 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 1 generation backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- This deviceK101874 GE Logiq P6/P6 ProGE Healthcare · 2010
Showing 5 of 221 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 221 · See all- K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · cites it directly220descendants
- K131527Logiq S8GE Healthcare · 2013 · 2 generations on219descendants
- K133034Logiq F SeriesGE Healthcare · 2014 · 3 generations on155descendants
- K133533Logiq EGE Healthcare · 2014 · 3 generations on149descendants
- K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2014 · cites it directly144descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −4 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −3 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −1 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| 0 (this device) | K101874 | GE Logiq P6/P6 Pro | GE Healthcare | 2010 | — |
| +1 | K122114 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2012 | 1 |
| +2 | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| +3 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
| +3 | K133533 | Logiq E | GE Healthcare | 2014 | — |
| +1 | K141261 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2014 | — |
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 | 2 | 0 |
| 2008 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K073297 | GE Logiq P6Summary page 1…onicPuhed Echo lInaging Systemn, 2ICER 892.1560, 90-lYO Diagnostic UltraoundTransducer, 21.CFR 892.I570, 90.TX Predicat Device(st~ K073297 GE LOCIQ P6 Ultorasound System K092271 GE LOGIQ E9 Diagnostic Ultrasound System Dcvicc Dcscri… | 2007 |
| * | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4Summary page 1…Diagnostic UltraoundTransducer, 21.CFR 892.I570, 90.TX Predicat Device(st~ K073297 GE LOCIQ P6 Ultorasound System K092271 GE LOGIQ E9 Diagnostic Ultrasound System Dcvicc Dcscrintion: The subject device consists of a mobile console with keyboar… | 2009 |
| † | K030934 | GE Logiq 9 Model 2375600 | 2003 |
What descends from it? (221)
See all 2212 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 15 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 26 of the 97 ancestors have a recall of any class.
- Of its descendants, K122114 (GE Healthcare, 2012) has gone furthest, with 220 descendants of its own.
- 1 other device also cites its predicate K073297.
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. 2010, 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 a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101874: GE Logiq P6/P6 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101874
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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