# K240243: EConsole2

- Pathway: 510(k) (Traditional)
- Applicant: DRTECH Corporation
- Decided: Sep 23, 2024 after 237 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 K896095 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231225: EConsole1, DRTECH Corporation (2023) Summary page 4.

## Indications for use
EConsole2 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). It is intended for both adult and pediatric populations.

Source page: https://510kreport.com/device/K240243
Methodology: https://510kreport.com/methodology