# K223550: DMX

- Pathway: 510(k) (Abbreviated)
- Applicant: Del Medical, Inc.
- Decided: Apr 10, 2023 after 136 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: 11 generations back to K801623 (1980). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152767: OTC12D Auto Radiographic System, Del Medical, Inc. (2015) Summary page 4.

## Indications for use
The DMX is a radiographic system used in hospitals, clinics, and medical practices. The DMX enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The DMX is not meant for mammography. The DMX can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The DMX is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes

Source page: https://510kreport.com/device/K223550
Methodology: https://510kreport.com/methodology