Cerebral Blood Flow Analysis System (CBP), Model CSCP-001A
by Toshiba America Medical Systems, In.C
510(k) K013214
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013214 | Date5 Oct 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Cerebral Blood Flow Analysis System (Cbp), Model Number Cscp-001A
- 510(k) Number
- FDA Product Code
- JAK
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cerebral Blood Flow Analysis System (CBP), Model CSCP-001A, is a post-processing software application designed for computed tomography (CT) scanners. It processes dynamic CT image data acquired post-contrast injection to generate perfusion maps, including cerebral blood flow (CBP), cerebral blood volume (CBV), mean transit time (MTT), and error region ratio (ERR). The system provides quantitative numeric measurements such as mean values, standard deviation, area, and distance to aid in clinical assessment. It falls under the classification of a system for X-ray tomography in radiology, enabling detailed evaluation of cerebral perfusion disturbances.
This software is intended for use with Toshiba Aquilion and Asteion CT scanners and is operated by trained physicians in clinical settings. It is supplied as a digital product, requiring no sterility or single-use considerations. The device is classified under FDA product code JAK and has received a 510(k) clearance with a decision of Substantially Equivalent (SESE) under the Radiology review panel. No specific MRI safety or physical size details are provided, but it is regulated as a Class II medical device under traditional clearance procedures.
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Questions
AI-generated answers, 1 Oct 2026
What is the Cerebral Blood Flow Analysis System (CBP) CSCP-001A used for?
The Cerebral Blood Flow Analysis System (CBP) CSCP-001A is a post-processing software application designed to analyze dynamic CT image data acquired after contrast injection. It generates perfusion maps, including cerebral blood flow (CBP), cerebral blood volume (CBV), mean transit time (MTT), and error region ratio (ERR). These maps help clinicians evaluate cerebral perfusion disturbances, such as those caused by strokes or other cerebrovascular conditions, by providing quantitative numeric measurements like mean values, standard deviation, area, and distance.
Which CT scanners is the CBP CSCP-001A compatible with?
The Cerebral Blood Flow Analysis System (CBP) CSCP-001A is specifically designed for use with Toshiba Aquilion and Asteion CT scanners. Compatibility is limited to these models, ensuring optimized performance and accurate perfusion map generation.
How is the CBP CSCP-001A supplied, and does it require sterilization?
The Cerebral Blood Flow Analysis System (CBP) CSCP-001A is supplied as a digital software product. Since it is purely software-based and does not involve physical hardware or consumables, there are no sterility requirements or single-use considerations. It is intended for use in clinical settings by trained physicians operating Toshiba CT scanners.
Is the CBP CSCP-001A a single-use or reusable device?
The CBP CSCP-001A is not a physical device requiring replacement after use. As a software application, it remains reusable indefinitely on compatible CT systems, provided the system meets the necessary technical specifications and the software is properly maintained and updated by the manufacturer.
What regulatory clearance does the CBP CSCP-001A hold?
The Cerebral Blood Flow Analysis System (CBP) CSCP-001A has received FDA 510(k) clearance under the product code JAK, classified as a system for X-ray tomography in radiology. The clearance was determined to be Substantially Equivalent (SESE) under the Radiology review panel, following traditional clearance procedures. This classification applies to its use as a diagnostic tool for cerebral perfusion analysis.