# K041688: GE Voluson 730 Pro/Expert Untrasound BT04

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jul 8, 2004 after 16 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003525 (2000). 2 ancestors in all.
708 later devices descend from it; 5 cite it directly.
0 of 711 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) Summary page 1.
- K032620: GE Voluson 730 Pro/Expert BT03 Ultrasound System, General Electric Co. (2003) Summary page 1.
- (no number) GE Logiq 9: named in the summary without a submission number

## Most influential descendants
- K061682: GE Voluson E8 Ultrasound System (2006), 554 descendants of its own
- K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM (2011), 445 descendants of its own
- K053435: GE Voluson I (2005), 407 descendants of its own
- K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System (2011), 404 descendants of its own
- K113758: Voluson E6/E8/E8EXPERT/E10 (2012), 402 descendants of its own

## Recalls of this device
- Feb 24, 2006 · Not classified · Z-1172-06: In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal/GYN (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/K041688
Methodology: https://510kreport.com/methodology