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Scenaria View 4.2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231574

by FUJIFILM Healthcare Americas Corporation

Identifiers

510(k) Number
K231574 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 Scenaria View 4.2 is a computed tomography (CT) X-ray imaging system, designed for high-resolution cross-sectional imaging of the body. It falls under the regulatory classification of Computed Tomography X-Ray (21 CFR 892.1750) and is intended for radiologic examinations across multiple specialties, including radiology, cardiology, and emergency care. This device enables detailed visualization of internal structures, facilitating accurate diagnosis and treatment planning. Its performance is optimized for diverse clinical settings, from inpatient departments to outpatient facilities.

The Scenaria View 4.2 is supplied as a reusable medical device, intended for use in controlled clinical environments such as hospitals and diagnostic centers. It is not classified as single-use and requires proper maintenance, calibration, and adherence to manufacturer guidelines for safe operation. The device is regulated under FDA 510(k) clearance (K231574) and is subject to compliance with applicable radiation safety standards. Storage and handling must follow established protocols to ensure imaging accuracy and device longevity.

Frequently asked questions

What is the Scenaria View 4.2 used for?

The Scenaria View 4.2 is a computed tomography (CT) X-ray imaging system designed for high-resolution cross-sectional imaging of the body. It supports radiologic examinations in multiple specialties, including radiology, cardiology, and emergency care, enabling detailed visualization of internal structures to aid in accurate diagnosis and treatment planning. Its versatility makes it suitable for diverse clinical settings, from inpatient departments to outpatient facilities.

Is the Scenaria View 4.2 a single-use or reusable device?

The Scenaria View 4.2 is a reusable medical device. It is intended for use in controlled clinical environments such as hospitals and diagnostic centers, where proper maintenance, calibration, and adherence to manufacturer guidelines are required to ensure safe and accurate operation. Reusability extends its utility in high-volume or long-term clinical settings.

What regulatory clearance does the Scenaria View 4.2 hold?

The Scenaria View 4.2 holds FDA 510(k) clearance under the classification of Computed Tomography X-Ray (21 CFR 892.1750). It was determined to be substantially equivalent to a predicate device and received clearance on October 12, 2023, with the 510(k) number K231574. This clearance ensures compliance with applicable radiation safety standards and regulatory requirements for CT imaging systems.

How should the Scenaria View 4.2 be stored and handled?

The Scenaria View 4.2 requires adherence to established storage and handling protocols to maintain imaging accuracy and device longevity. Proper storage includes protection from environmental factors such as moisture, dust, and extreme temperatures. Handling should follow manufacturer guidelines to prevent damage and ensure consistent performance. Regular maintenance and calibration are also critical to uphold the device’s functionality and safety.

What clinical environments is the Scenaria View 4.2 intended for?

The Scenaria View 4.2 is optimized for use in controlled clinical environments such as hospitals, diagnostic centers, and outpatient facilities. Its design supports diverse specialties, including radiology, cardiology, and emergency care, where detailed cross-sectional imaging is essential. The device’s performance is tailored to accommodate the demands of both inpatient and outpatient settings, ensuring versatility in clinical applications.

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. Sources consulted: Scenaria View - FUJIFILM Healthcare Americas Corporation, Scenaria View 4.2 (K231574) — FDA 510 (k) | Innolitics, PDF October 12, 2023 Fujifilm Healthcare Americas Corporation Chaitrali ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
FUJIFILM Healthcare Americas Corporation

Sources (1)

  • FDA 510(k) K231574 24 fields · synced Oct 5, 2026