# K092830: Digital X-Ray Imaging System, Model DRC-1000

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Jul 21, 2010 after 310 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 6 generations back to K981556 (1998). 12 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems, Sedecal., Sa. (2009) Summary page 1.

## Most influential descendants
- K091090: Digital Flat Panel X-Ray Detector, Model Xmaru 1717 (2010), 17 descendants of its own
- K142475: EVS 4343 (2015), 13 descendants of its own
- K162555: Evs 4343, Evs 4343G (2016), 7 descendants of its own
- K192400: Evs 4343A, Evs 4343AG, Evs 3643A, Evs 3643AG (2019), 6 descendants of its own
- K151942: EVS 3643 (2015), 4 descendants of its own

## Indications for use
Digital X-ray Imaging System, DRC-1000, is intended for by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Source page: https://510kreport.com/device/K092830
Methodology: https://510kreport.com/methodology