# K032620: GE Voluson 730 Pro/Expert BT03 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Oct 10, 2003 after 45 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003525 (2000). 1 ancestor in all.
864 later devices descend from it; 5 cite it directly.
2 of 866 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000)
- (no number) GE Logiq 9: named in the summary without a submission number

## Most influential descendants
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K041688: GE Voluson 730 Pro/Expert Untrasound BT04 (2004), 708 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K032620
Methodology: https://510kreport.com/methodology