# K102408: Digital Diagnostic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: DRGEM Corporation
- Decided: Dec 27, 2010 after 126 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.
17 later devices descend from it; 4 cite it directly.
0 of 30 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
- K192364: GXR-Series Diagnostic X-Ray System (2019), 11 descendants of its own
- K202572: GXR-Series Diagnostic X-Ray System (2020), 8 descendants of its own
- K242119: Innovision-Exii (2025), 2 descendants of its own
- K233530: EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) (2024), 2 descendants of its own
- K192453: Diamond-5A/6A/8A (2019), 2 descendants of its own

## Indications for use
The DIAMOND-5A,6A,8A Digital Diagnostic X-ray System 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/K102408
Methodology: https://510kreport.com/methodology