# K200852: EchoPAC Software Only, EchoPAC Plug-In

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Sep 18, 2020 after 171 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: 24 generations back to K935595 (1995). 264 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170847: EchoPAC Software Only, EchoPAC Plug-in, GE Medical Systems Ultrasound and Primary Care Diagnostics (2017) Summary page 4.
- K182450: Vivid S60N, Vivid S70N, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 4.
- K181685: Vivid E80, Vivid E90, Vivid E95, GE Medical Systems Ultrasound and Primary Care Diagnostics (2018) Summary page 4.
- K200743: Vivid E80/ Vivid E90/ Vivid E95, Ge Medical Systems Ultrasound And (2020). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- 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
- K261623: EchoPAC Software Only / EchoPAC Plug-in (v211) (2026), 0 descendants of its own

## Indications for use
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D). Clinical applications include: Fetal/Obstetrics; 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, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.

Source page: https://510kreport.com/device/K200852
Methodology: https://510kreport.com/methodology