510(k) · Cleared
Recalled · Class II · 2018GE Logiq P6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 18, 2007 as substantially equivalent to K060993 (General Electric Co., 2006) after a 25-day review. Its family tree reaches back 4 generations to 2001. 224 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 18, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010329 (2001). 224 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010329 LOGIQ 500General Electric Co. · 2001
- 3 generations backK014097 GE Logiq 5GE Medical Systems · 2002 · Recalled
- 2 generations backK032974 GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003
- 1 generation backK060993 GE Logiq P5 and A5General Electric Co. · 2006
- This deviceK073297 GE Logiq P6General Electric Co. · 2007
- Descendant · cites it directly · 221 of its ownK101874 GE Logiq P6/P6 ProGE Healthcare · 2010
- Descendant · 2 generations on · 220 of its ownK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- Descendant · 3 generations on · 219 of its ownK131527 Logiq S8GE Healthcare · 2013
- Descendant · 4 generations on · 155 of its ownK133034 Logiq F SeriesGE Healthcare · 2014
- Descendant · 4 generations on · 149 of its ownK133533 Logiq EGE Healthcare · 2014
Showing 5 of 224 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 224 · See all- K101874GE Logiq P6/P6 ProGE Healthcare · 2010 · cites it directly221descendants
- K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · 2 generations on220descendants
- K131527Logiq S8GE Healthcare · 2013 · 3 generations on219descendants
- K133034Logiq F SeriesGE Healthcare · 2014 · 4 generations on155descendants
- K133533Logiq EGE Healthcare · 2014 · 4 generations on149descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010329 | LOGIQ 500 | General Electric Co. | 2001 | — |
| −3 | K014097 | GE Logiq 5 | GE Medical Systems | 2002 | 1 |
| −2 | K032974 | GE Logiq 5 Pro or Expert | General Electric Co. | 2003 | — |
| −1 | K060993 | GE Logiq P5 and A5 | General Electric Co. | 2006 | — |
| 0 (this device) | K073297 | GE Logiq P6 | General Electric Co. | 2007 | — |
| +1 | K101874 | GE Logiq P6/P6 Pro | GE Healthcare | 2010 | — |
| +2 | K122114 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2012 | 1 |
| +3 | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| +4 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
| +4 | K133533 | Logiq E | GE Healthcare | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K060993 | GE Logiq P5 and A5Summary page 1…Ultrasound System Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ P5 Diagnostic Ultrasound System, K060993 currently in commercial distribution. 4. Device Description: The GE LOGIQ P6 is full-featured, general-pu… | 2006 |
What descends from it? (224)
See all 2242 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 |
|---|---|---|---|---|
| Dec 28, 2018 | Class II | Z-0788-2019 | Device Design | Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes. |
| Dec 23, 2011 | Not classified | Z-0834-2012 | Software design | GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K101874 (GE Healthcare, 2010) has gone furthest, with 221 descendants of its own.
- 11 other devices also cite its predicate K060993.
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. 2007, 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 the evaluation of soft tissue and blood flow in the clinical applications 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); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073297: GE Logiq P6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073297
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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