# K013214: Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 5, 2001 after 9 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: 2 generations back to K880965 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010042: CT Perfusion 2, General Electric Co. (2001) Summary page 1.
- K982536: Perfusion CT (Computed Tomography) Software Package, Siemens Corp. (1998) Summary page 1.

## Indications for use
The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR - CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.

Source page: https://510kreport.com/device/K013214
Methodology: https://510kreport.com/methodology