# K941611: TDA-4000/A4

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: May 13, 1994 after 39 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013608: Digital Radiography System, Model DFP-8000D (2001), 59 descendants of its own
- 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

## Recalls of this device
- May 27, 2003 · Not classified · Z-0100-04: Images display with wrong patient demographics.

Source page: https://510kreport.com/device/K941611
Methodology: https://510kreport.com/methodology