# K081482: CSBP-001A Body Organ Perfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 11, 2008 after 14 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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 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.
- K060937: Brilliance Volume, Philips Medical Systems (Cleveland), Inc. (2006). Our reading of the summary gave K060397, FDA’s number for RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion… (PAJUNK GmbH Medizintechnologie). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Philips Brilliance CT”.

## Indications for use
This software package has been designed to evaluate the perfusion of organs and tumors. The software allows for the calculation of blood flow, blood volume and permeabi'lity from sets pf images reconstructed from dynamic CT data acquired after the injection of a contrast bolus. The package also allows for the independent calculation of arterial and portal venous component of hepatic perfusion. It supports the evaluation of regions of interest and the visual inspection of time density curves.

Source page: https://510kreport.com/device/K081482
Methodology: https://510kreport.com/methodology