510(k) · Cleared
ClearedGE Voluson 730 Pro/Expert BT03 Ultrasound System
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 Oct 10, 2003 as substantially equivalent to K003525 (Medison America, Inc., 2000) after a 45-day review. Its family tree reaches back 1 generation to 2000. 2 of the 866 devices in its family, counting itself, have a Class I recall. 864 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 45 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003525 (2000). 864 later devices descend from it, 5 citing it directly. 2 of the 866 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- This deviceK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- Descendant · cites it directly · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 708 of its ownK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- Descendant · 2 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 864 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 864 · See all- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · cites it directly800descendants
- K041688GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · cites it directly708descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 2 generations on588descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| 0 (this device) | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| +1 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| +2 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +2 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 12 | 0 |
| 2010 | 17 | 0 |
| 2011 | 26 | 0 |
| 2012 | 38 | 0 |
| 2013 | 36 | 0 |
| 2014 | 50 | 0 |
| 2015 | 53 | 0 |
| 2016 | 58 | 0 |
| 2017 | 73 | 0 |
| 2018 | 63 | 0 |
| 2019 | 46 | 0 |
| 2020 | 65 | 0 |
| 2021 | 48 | 0 |
| 2022 | 53 | 0 |
| 2023 | 50 | 0 |
| 2024 | 54 | 0 |
| 2025 | 65 | 2 |
| 2026 | 47 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K003525 | Voluson 730 Diagnostic Ultrasound System | 2000 |
| * | — | GE Logiq 9 Named without a submission number |
What descends from it? (864)
See all 8645 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
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 ultrasound evaluation of Fetal; AbdominaVGYN (including infertility monitoring of follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032620: GE Voluson 730 Pro/Expert BT03 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032620
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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