# K982196: Digital Radiographic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 6, 1998 after 106 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: 1 generation back to K862120 (1986). 1 ancestor in all.
221 later devices descend from it; 4 cite it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862120: SCX System, General Electric Co. (1986) Summary page 1.
- (no number) SG-60 vertical wallstand: named in the summary without a submission number

## Most influential descendants
- K992066: Revolution TX/I Digital Radiographic Table System (1999), 104 descendants of its own
- K012389: Revolution XR/D Digital Radiographic Imaging System (2001), 103 descendants of its own
- K992794: Stingray DR, Model 1 (1999), 103 descendants of its own
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), 78 descendants of its own
- K123098: Xgeo GC80 (2013), 48 descendants of its own

## Indications for use
The Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K982196
Methodology: https://510kreport.com/methodology