# K192453: Diamond-5A/6A/8A

- Pathway: 510(k) (Special)
- Applicant: DRGEM Corporation
- Decided: Oct 1, 2019 after 22 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: 7 generations back to K981556 (1998). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102408: Digital Diagnostic X-Ray System, DRGEM Corporation (2010) Summary page 4.

## Most influential descendants
- K202156: Diamond-5A/6A/8A (2020), 1 descendant of its own
- K220271: Hand Diagnostic Radiography Imaging System (2022), 0 descendants of its own

## Indications for use
DIAMOND-5A/6A/8A, is a stationary digital diagnostic x-ray system that is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K192453
Methodology: https://510kreport.com/methodology