# K242015: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

- Pathway: 510(k) (Traditional)
- Applicant: DRGEM Corporation
- Decided: Dec 16, 2024 after 159 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: 19 generations back to K981556 (1998). 59 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K201124: TOPAZ Mobile DR System, DRGEM Corporation (2020) Summary page 5.

## Most influential descendants
- 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 X-ray System’ is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

Source page: https://510kreport.com/device/K242015
Methodology: https://510kreport.com/methodology