# K201124: TOPAZ Mobile DR System

- Pathway: 510(k) (Special)
- Applicant: DRGEM Corporation
- Decided: May 19, 2020 after 22 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K981556 (1998). 58 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183292: Topaz Mobile DR System, DRGEM Corporation (2019) Summary page 4.

## Most influential descendants
- K242015: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) (2024), 2 descendants of its own
- K260085: RAYMO Mobile X-ray System (Model: RAYMO) (2026), 0 descendants of its own
- K251443: PROMO (2025), 0 descendants of its own

## Indications for use
The TOPAZ Mobile DR System, is a mobile X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient’s anatomy. This device is not intended for mammography, bone density, fluoroscopy and angiography applications.

Source page: https://510kreport.com/device/K201124
Methodology: https://510kreport.com/methodology