# K193644: E-Com DR-2000 DR

- Pathway: 510(k) (Traditional)
- Applicant: Livermoretech, Inc.
- Decided: Feb 14, 2020 after 46 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T, Sedecal., Sa. (2013) Summary page 4.

## Most influential descendants
- K203703: I-Q View (2021), 0 descendants of its own

## Indications for use
Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

Source page: https://510kreport.com/device/K193644
Methodology: https://510kreport.com/methodology