Perfusion CT (Computed Tomography) Software Package

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982536 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Perfusion CT Software Package used for?

  The Perfusion CT Software Package is designed to assess the type and extent of perfusion disturbances by visualizing blood flow parameters. It works with a computed tomography x-ray system to produce cross-sectional images through computer reconstruction of x-ray transmission data taken at different angles, aiding in diagnostic evaluation of blood flow.

• How is the Perfusion CT Software Package supplied and is it reusable?

  The software is supplied as part of a Class II CT scanner and is intended for single-use in clinical settings. It is not reusable, meaning it should not be reprocessed or used again after initial deployment, requiring proper storage and handling to maintain functionality.

• What regulatory pathway was used for the Perfusion CT Software Package?

  The device received FDA 510(k) clearance under submission K982536, indicating it was found substantially equivalent to a legally marketed predicate device. It was reviewed by the Radiology Advisory Committee as part of the traditional 510(k) process.