# K220940: EchoPAC Software Only, EchoPAC Plug-in

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jul 22, 2022 after 113 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 25 generations back to K935595 (1995). 275 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200852: EchoPAC Software Only, EchoPAC Plug-In, GE Medical Systems Ultrasound and Primary Care Diagnostics (2020) Summary page 4.
- K211488: Logiq E10, GE Healthcare (2021) Summary page 4.
- K202658: Vivid E80/ Vivid E90/ Vivid E95, GE Medical Systems Ultrasound and Primary Care Diagnostics (2021) Summary page 5.
- K202132: Venue, GE Medical Systems Ultrasound and Primary Care Diagnostics (2020) Summary page 5.

## Most influential descendants
- 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; Thoracic/Pleural and Intra-Luminal.

Source page: https://510kreport.com/device/K220940
Methodology: https://510kreport.com/methodology