510(k) · Cleared
ClearedGE Logiq P5 and A5
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 May 3, 2006 as substantially equivalent to K032974 (General Electric Co., 2003) after a 22-day review. Its family tree reaches back 3 generations to 2001. 653 later devices descend from it.
- Decided
- May 3, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010329 (2001). 653 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK010329 LOGIQ 500General Electric Co. · 2001
- 2 generations backK014097 GE Logiq 5GE Medical Systems · 2002 · Recalled
- 1 generation backK032974 GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003
- This deviceK060993 GE Logiq P5 and A5General Electric Co. · 2006
- Descendant · cites it directly · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · cites it directly · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 3 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 4 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
Showing 5 of 653 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 653 · See all- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · cites it directly584descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · cites it directly582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · 3 generations on472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 4 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010329 | LOGIQ 500 | General Electric Co. | 2001 | — |
| −2 | K014097 | GE Logiq 5 | GE Medical Systems | 2002 | 1 |
| −1 | K032974 | GE Logiq 5 Pro or Expert | General Electric Co. | 2003 | — |
| 0 (this device) | K060993 | GE Logiq P5 and A5 | General Electric Co. | 2006 | — |
| +1 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +1 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +2 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 17 | 0 |
| 2012 | 25 | 0 |
| 2013 | 25 | 0 |
| 2014 | 37 | 0 |
| 2015 | 38 | 0 |
| 2016 | 40 | 0 |
| 2017 | 62 | 0 |
| 2018 | 50 | 0 |
| 2019 | 37 | 0 |
| 2020 | 54 | 0 |
| 2021 | 38 | 0 |
| 2022 | 45 | 0 |
| 2023 | 39 | 0 |
| 2024 | 46 | 0 |
| 2025 | 49 | 0 |
| 2026 | 33 | 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 |
|---|---|---|---|
| * | K032974 | GE Logiq 5 Pro or ExpertSummary page 1…Ultrasonic Pulsed Doppler Imaging System, 21 CIFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ SPRO diagnostic ultrasound system, 510(k) Numbers K032974 currently in commercial distribution. 4. Device Description: The GE LOGIQ PS & AS are full-featured, gener… | 2003 |
What descends from it? (653)
See all 65312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080935 | Sonix MDP Ultrasound Scanner | 2008 | 584 |
| K083095 | Sonixtouch Ultrasound System | 2008 | 582 |
| K073297 | GE Logiq P6 | 2007 | 224 |
| K092691 | DC-7 Diagnostic Ultrasound System | 2009 | 176 |
| K112122 | VENUE 40 | 2011 | 160 |
| K101041 | DC-7 Diagnostic Ultrasound System | 2010 | 130 |
| K103583 | DC-7 Diagnostic Ultrasound System | 2010 | 123 |
| K093462 | Sonix Ultrasound Scanner | 2009 | 79 |
| K120060 | E-CUBE 9 | 2012 | 23 |
| K102104 | GE Vivid P3 Diagnostic Ultrasound Imaging System | 2010 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K080935 (Ultrasonix Medical Corporation, 2008) has gone furthest, with 584 descendants of its own.
- 1 other device also cites its predicate K032974.
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.
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: 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/K060993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060993: GE Logiq P5 and A5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060993
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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