CT Perfusion 2

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

510(k) Number

K010042 ↗

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 CT Perfusion 2 used for in medical imaging?

  The CT Perfusion 2 is designed for dynamic perfusion imaging, which assesses blood flow, volume, and tissue perfusion in vascular structures and organs. This helps clinicians evaluate conditions like stroke, tumors, and cardiovascular diseases by providing quantitative metrics during contrast-enhanced CT scans. The rapid sequential imaging capability distinguishes it from standard CT scanners, enabling precise diagnostic assessments.

• Is the CT Perfusion 2 a single-use or reusable device?

  The CT Perfusion 2 is supplied as a reusable medical imaging system. Unlike disposable devices, it requires regular calibration and maintenance to ensure consistent performance and accuracy. The manufacturer provides guidelines for upkeep, which must be followed to comply with clinical standards and regulatory requirements.

• What regulatory approval does the CT Perfusion 2 hold?

  The CT Perfusion 2 holds FDA 510(k) clearance under product code JAK, with the initial clearance granted in 2001. This classification indicates the device is deemed substantially equivalent to a legally marketed predicate device. The clearance was reviewed by the Radiology Advisory Committee (RA) and falls under the traditional 510(k) pathway.

• Where can the CT Perfusion 2 be used, and what settings are appropriate?

  The CT Perfusion 2 is intended for use in radiology departments within both clinical and research settings. Its advanced perfusion imaging capabilities make it suitable for environments where detailed vascular and organ assessments are required. The device is not limited to a specific patient population but is particularly valuable in diagnosing complex conditions like cerebrovascular accidents or oncological evaluations.

• Does the CT Perfusion 2 require any special handling or storage conditions?

  While the provided data does not specify sterility or unique storage requirements, as a reusable imaging system, the CT Perfusion 2 must be stored in a clean, controlled environment to prevent contamination and ensure optimal performance. Manufacturer guidelines should be followed for calibration, maintenance, and operational protocols to extend the device’s lifespan and reliability.