# K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 1, 2011 after 30 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: 5 generations back to K003525 (2000). 5 ancestors in all.
404 later devices descend from it; 3 cite it directly.
0 of 410 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM, GE Healthcare (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K111149: Hanarostent Biliary (NNN), M.I.Tech Co., Ltd. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own

## Recalls of this device
- Jul 13, 2012 · Class II · Z-1833-2013: GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an inter

## Indications for use
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetab1 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 Intraoperative (abdominal, PV and neurological).

Source page: https://510kreport.com/device/K112213
Methodology: https://510kreport.com/methodology