# K072693: CSNP-001A Neuro Package

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 1, 2007 after 38 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CSCP-00IA Cerebral Bloop Perfusion Analysis Package: named in the summary without a submission number

## Indications for use
The CSNP-001A is a post processing package that has the capability to perform brain perfusion studies to include whole brain studies, when used by a trained physician, by using data that is acquired on a time sequential basis. This package provides the physician with the following information that can then be measured and analyzed in the assessment of brain trauma or stroke: TDC (time density curve) CBF: Blood flow in the capillary vessels of the cerebral tissues. CBV: Blood volume in the capillary vessels of the cerebral tissues. MTT: Mean transit time of blood in the capillary vessels f the cerebral vessels. TTP: Time to peak of the TDCs. DLY: Delay of each voxel curve from the arterial curves.

Source page: https://510kreport.com/device/K072693
Methodology: https://510kreport.com/methodology