# K131685: GE Echopac

- Pathway: 510(k) (Traditional)
- Applicant: Ge Vingmed Ultrasound AS
- Decided: Sep 24, 2013 after 106 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: 9 generations back to K003931 (2001). 17 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123894: GE Echopac, Ge Vingmed Ultrasound AS (2013) Summary page 1.

## Most influential descendants
- K150085: GE EchoPAC (2015), 7 descendants of its own
- 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

## Indications for use
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal: Abdominal (including renal and GYN); Urology (including prostate); Pediatric: Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Tranarectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, &vascular). The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

Source page: https://510kreport.com/device/K131685
Methodology: https://510kreport.com/methodology