510(k) · Cleared
ClearedGE Vivid P3 Diagnostic Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wipro GE Healthcare Private, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 1, 2010 as substantially equivalent to K072797 (General Electric Co., 2007) and 3 other predicates after a 66-day review. Its family tree reaches back 7 generations to 1987. 1 later device descends from it.
- Decided
- Oct 1, 2010
- Review
- 66 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K863700 (1987). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 6 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
- 5 generations backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
- 4 generations backK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
- 3 generations backK032477 GE Logiq BookGeneral Electric Co. · 2003
- 2 generations backK050126 GE Logiq TwinGeneral Electric Co. · 2005
- 1 generation backK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
- This deviceK102104 GE Vivid P3 Diagnostic Ultrasound Imaging SystemWipro GE Healthcare Private, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK112371 Logiq P3GE Healthcare · 2011
Most influential descendants
Showing 1 of 1 · See all- K112371Logiq P3GE Healthcare · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| −6 | K953752 | RT55 Diagnostic Ultrasound System | General Electric Co. | 1996 | — |
| −5 | K012560 | GE Logiq A100 MP, Model 2272413 | General Electric Co. | 2001 | — |
| −4 | K014206 | Logiqbook | General Electric Co. | 2002 | 1 |
| −3 | K032477 | GE Logiq Book | General Electric Co. | 2003 | — |
| −2 | K050126 | GE Logiq Twin | General Electric Co. | 2005 | — |
| −1 | K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E… | General Electric Co. | 2007 | — |
| 0 (this device) | K102104 | GE Vivid P3 Diagnostic Ultrasound Imaging System | Wipro GE Healthcare Private, Ltd. | 2010 | — |
| +1 | K112371 | Logiq P3 | GE Healthcare | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…Summary page 2…ary - IYN - 21ICFR 892.1550; IYO - 21CFR 892.1560 & Secondary - ITX - 2ICFR 892.1570 Predicate Device(s): GE Logiq eli & Vivid e - K072797, GE Logiq P5/AS K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079 Devce… | 2007 |
| * | K060993 | GE Logiq P5 and A5Summary page 2…550; IYO - 21CFR 892.1560 & Secondary - ITX - 2ICFR 892.1570 Predicate Device(s): GE Logiq eli & Vivid e - K072797, GE Logiq P5/AS K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079 Devce escipton:The Vivid… | 2006 |
| * | K073297 | GE Logiq P6Summary page 2…Secondary - ITX - 2ICFR 892.1570 Predicate Device(s): GE Logiq eli & Vivid e - K072797, GE Logiq P5/AS K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079 Devce escipton:The VividTM P3 is a high performance, mobile Color Doppler… | 2007 |
| * | K092079 | Modification to GE Vivid S5 and S6 Diagnostic UltrasoundSummary page 2…2ICFR 892.1570 Predicate Device(s): GE Logiq eli & Vivid e - K072797, GE Logiq P5/AS K060993, GE Logiq P6 K073297, GE Vivid S5/S6 K092079 Devce escipton:The VividTM P3 is a high performance, mobile Color Doppler… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112371 | Logiq P3 | 2011 | 0 |
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 23 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K112371 (GE Healthcare, 2011) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K072797.
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 intended for use by a qualified physician for ultrasound evaluation of
Cardiac (adult and pediatric), Peripheral Vascular, Fetal/Obstetrics, Abdominal
(including GYN), Pediatric, Small Organ (including breast, testes, thyroid), Neonatal
Cephalic, Adult Cephalie, Intra operative (abdominal, thoracic and peripheral), Musculo-
skeletal Conventional, Urology (including prostate), Transrectal and Transvaginal.
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/K102104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102104: GE Vivid P3 Diagnostic Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102104
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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