# K150085: GE EchoPAC

- Pathway: 510(k) (Traditional)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Mar 2, 2015 after 46 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 138 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131685: GE Echopac, Ge Vingmed Ultrasound AS (2013) Summary page 5.
- K142323: Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System, Ge Medical Systems Israel, Ltd. (2014) Summary page 5.

## Most influential descendants
- K170847: EchoPAC Software Only, EchoPAC Plug-in (2017), 4 descendants of its own
- K200852: EchoPAC Software Only, EchoPAC Plug-In (2020), 3 descendants of its own
- K220940: EchoPAC Software Only, EchoPAC Plug-in (2022), 2 descendants of its own
- K251342: EchoPAC Software Only / EchoPAC Plug-in (2025), 1 descendant of its own
- K191493: Ventripoint Medical System Plus (VMS+) 3.0 (2019), 1 descendant of its own

## Indications for use
The GE EchoPAC is indicated for diagnostic review and analysis of ultrasound images acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN) ; Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

Source page: https://510kreport.com/device/K150085
Methodology: https://510kreport.com/methodology