# K041027: Digital Radiography System with Flat Panel Detector, Model DFP8000D

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: May 14, 2004 after 23 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771298 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013608: Digital Radiography System, Model DFP-8000D, Toshiba America Medical Systems, In.C (2001) Summary page 1.
- K993038: Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.), Toshiba America Medical Systems, In.C (1999) Summary page 1.

## Indications for use
This device is a digital radiography system used in diagnostic X-ray angiography system configuration. This X-ray angiography system is indicated for use in diagnostic and interventional cardiac examinations. It is intended to replace images obtained through the image intensifier technology.

Source page: https://510kreport.com/device/K041027
Methodology: https://510kreport.com/methodology