# K052884: Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 26, 2005 after 13 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941611 (1994). 2 ancestors in all.
57 later devices descend from it; 4 cite it directly.
0 of 60 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.

## Most influential descendants
- K081582: Infx-8000V, Infinix-Cfi and Infinix Vfi (2008), 23 descendants of its own
- K101868: Infinix-I Interventional Angiography System Model Infx-8000V (2010), 21 descendants of its own
- K120073: Infx-8000V with (2012), 20 descendants of its own
- K081624: Infx-8000F (Infinix Csi and Infinix Dpi) (2008), 13 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own

## Recalls of this device
- Nov 8, 2012 · Class II · Z-0994-2013: Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed o
- Oct 1, 2007 · Not classified · Z-0293-2008: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

## 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 procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower limb blood vessels. It is intended to replace images obtained through the image intensifier technology.

Source page: https://510kreport.com/device/K052884
Methodology: https://510kreport.com/methodology