# K090504: CSBP-001A Body Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Mar 5, 2009 after 7 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 27 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052839: CT Perfusion 4, GE Healthcare (2006) Summary page 1.
- K073373: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2007) Summary page 1.

## Most influential descendants
- K121213: Vitreaadvanced (2012), 8 descendants of its own
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own
- K151988: Visible Patient Suite (2015), 4 descendants of its own
- K212896: Visible Patient Suite (2021), 3 descendants of its own
- K250237: InferOperate Suite (2025), 1 descendant of its own

## Indications for use
The Body Perfusion System software package is a noninvasive post-processing package that has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring. It should be used by a trained and qualified physician.

Source page: https://510kreport.com/device/K090504
Methodology: https://510kreport.com/methodology