# K013608: Digital Radiography System, Model DFP-8000D

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 15, 2001 after 15 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: 1 generation back to K941611 (1994). 1 ancestor in all.
59 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941611: TDA-4000/A4, Toshiba America Medical Systems, In.C (1994) Summary page 1.

## Most influential descendants
- K052884: Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector (2005), 57 descendants of its own
- 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

## Recalls of this device
- Nov 15, 2005 · Not classified · Z-0532-06: In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
- Jun 18, 2004 · Not classified · Z-1337-04: Defect in the mirroring unit.

## Indications for use
The Digital Radiography System, Model DFP-8000D is a Digital Radiography Processor used in diagnostic X-ray angiography systems. This system processes, displays, and records digital images obtained from the detectors of X-ray TV systems (such as CCD cameras), and replays the recorded images for image diagnosis. This system is intended for use in diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels, and lower limb blood vessels.

Source page: https://510kreport.com/device/K013608
Methodology: https://510kreport.com/methodology