# K073259: Xidf-100A/B1 Image Processor

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 20, 2007 after 30 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K002424 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002424: 3D Angiographic Imaging System, Model Xidf-100A, Toshiba America Medical Systems, In.C (2000) Summary page 2.
- K042646: Dynact, Siemens Medical Systems, Inc. (2004) Summary page 2.

## Indications for use
This device is designed to be used with Toshiba Infinix Angiography X-ray Systems and a 3D Workstation. The image processor receives 2D images and converts the data to 3D images sets that are transmitted to the 3D Workstation for viewing. The device is indicated for imaging both hard and soft tissue, as well as other internal body structures to facilitate diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K073259
Methodology: https://510kreport.com/methodology