# K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Feb 8, 2011 after 281 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: 4 generations back to K003525 (2000). 4 ancestors in all.
445 later devices descend from it; 8 cite it directly.
0 of 450 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061682: GE Voluson E8 Ultrasound System, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- 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
- K122327: Voluson E6/E8/E8EXPERT/E10 (2012), 365 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own
- K120741: Voluson S6, Voluson S8 (2012), 295 descendants of its own

## Indications for use
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN. pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and Pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and lntraoperative (abdominal, PV and neurological).

Source page: https://510kreport.com/device/K101236
Methodology: https://510kreport.com/methodology