# K131937: Voluson I/E

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 24, 2013 after 89 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: 17 generations back to K935595 (1995). 119 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053435: GE Voluson I, General Electric Co. (2005) Summary page 1.
- K122327: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012) Summary page 1.
- K120741: Voluson S6, Voluson S8, GE Healthcare (2012) Summary page 1.
- K122387: Voluson P6, Voluson P8, GE Healthcare (2012) Summary page 1.

## Most influential descendants
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 descendants of its own
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (2016), 23 descendants of its own
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (2017), 22 descendants of its own
- K173090: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (2018), 21 descendants of its own
- K182679: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (2018), 10 descendants of its own

## Indications for use
The device is a general purpose ultrasound system. Specific clinical applications include: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal

Source page: https://510kreport.com/device/K131937
Methodology: https://510kreport.com/methodology