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FCT iSTREAM Phase 1

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233583

by FUJIFILM Healthcare Americas Corporation

Identifiers

510(k) Number
K233583 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FCT iSTREAM Phase 1 is a Computed Tomography (CT) Scanner designed for perfusion imaging, enabling quantitative assessment of blood flow and tissue perfusion in the brain. It integrates advanced imaging technology to support diagnostic evaluations in neurological conditions, particularly stroke and vascular disorders, by providing high-resolution, dynamic contrast-enhanced scans.

This device is intended for use in clinical settings such as hospitals and specialized imaging centers, where it is supplied as a reusable medical system. It requires proper installation, calibration, and maintenance by trained personnel in accordance with manufacturer guidelines. The FCT iSTREAM Phase 1 holds FDA 510(k) clearance and MDR authorization, ensuring compliance with regulatory standards for diagnostic imaging equipment. Its operation adheres to standard MRI safety protocols, and its performance is validated through clinical validation studies.

Frequently asked questions

What types of neurological conditions can the FCT iSTREAM Phase 1 help diagnose, and how does it do this?

The FCT iSTREAM Phase 1 is specifically designed for perfusion imaging to assess blood flow and tissue perfusion in the brain. It is particularly useful for diagnosing and evaluating neurological conditions like stroke and vascular disorders by providing high-resolution, dynamic contrast-enhanced CT scans. These scans allow clinicians to quantitatively measure cerebral blood flow, volume, and transit time, aiding in precise diagnostic assessments.

Is the FCT iSTREAM Phase 1 a single-use or reusable device, and what does this mean for maintenance and upkeep?

The FCT iSTREAM Phase 1 is a reusable medical system, meaning it is built to be installed and used repeatedly in clinical settings like hospitals or imaging centers. Since it is not single-use, it requires proper installation, calibration, and regular maintenance by trained personnel to ensure consistent performance and safety. The manufacturer provides guidelines to follow for optimal operation and longevity.

How does the FCT iSTREAM Phase 1 comply with regulatory standards, and what does this mean for healthcare providers?

The FCT iSTREAM Phase 1 holds both FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with regulatory standards for diagnostic imaging equipment. This means healthcare providers can trust that the device meets established safety and performance criteria, reducing risks associated with its use in clinical settings like hospitals and imaging centers.

What safety protocols should be followed when operating the FCT iSTREAM Phase 1, particularly in relation to MRI safety?

The FCT iSTREAM Phase 1 adheres to standard MRI safety protocols during its operation, ensuring that risks associated with electromagnetic interference and patient safety are minimized. This includes following guidelines for patient positioning, equipment placement, and monitoring during scans to maintain a safe clinical environment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
FUJIFILM Healthcare Americas Corporation

Sources (2)

  • FDA 510(k) K233583 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026