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510(k) Data Aggregation
K Number
K242838Device Name
QuickRad
Manufacturer
Date Cleared
2025-02-21
(155 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Aikenist Technologies Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
QuickRad is a web-based PACS intended for use in radiology centers, diagnostic labs, and hospitals. It is designed to receive, store, transmit, process, and display medical images and associated data from various DICOM-compliant sources, including CT scanners, MRI systems, ultrasound machines, and X-ray devices. The system enhances communication and accessibility by allowing distributed access to images and data across computer networks. QuickRad also offers optional integration with FDA-cleared third-party Al models, enabling the visualization of Al-generated outputs. The system displays these outputs "as-is," with the safety and effectiveness of the Al models being covered under the original third-party manufacturer's regulatory clearance.Mammographic images may only be interpreted using a monitor that meets the technical specifications identified by the FDA. The system is designed for utilization by proficient and certified medical practitioners, including physicians, radiologists, and medical technicians.
Device Description
QuickRad is a web-based PACS designed to optimize radiology workflows and enhance clinical efficiency. It allows seamless receipt, management, and processing of DICOM images from various modalities, including CT, MRI, ultrasound, X-ray, and more.
Key Features and Functions:
- Comprehensive Radiology Management: QuickRad provides end-to-end functionality for the storage, transmission, processing, and visualization of medical images, ensuring seamless collaboration across healthcare networks.
- Zero Footprint Viewer (ZFP): QuickRad's ZFP viewer offers cross-platform accessibility without the need for additional native software installation. It is compatible with macOS, Windows, Ubuntu and Chrome, Edge, Firefox browsers.
- . Enhanced Viewer Options: QuickRad ensures that all scans are displayed with true-to-source fidelity, offering optional FDA-cleared viewer integrations that enhance diagnostic accuracy.
- . Advanced 3D Viewer: QuickRad's 3D viewer empowers radiologists with cutting-edge image analysis tools, including:
- o Smooth stack scrolling, zooming, panning, and reset options.
- O Measurement tools for length, angles, and annotations.
- Advanced visualization techniques such as Multiplanar Reconstruction (MPR) and Maximum Intensity O Projection (MIP).
- O PET scan mode with customizable contrast settings, annotation capabilities, and snapshot tools for enhanced diagnostic insights.
- . Smart Reporting Editor: QuickRad includes a modality-specific report editor that simplifies report creation. Pre-built templates for various imaging studies ensure consistent report generation with voiceenabled editing features.
- . AI Integration: QuickRad offers optional integration with FDA-cleared third-party AI models, allowing radiologists to review AI-generated results directly within the platform. The AI output is displayed alongside original images for confirmation by qualified medical professionals.
- DICOM Compliance: Fully compliant with DICOM standards, QuickRad guarantees secure and interoperable ● image and data exchange across systems, ensuring compatibility with a wide range of imaging devices.
- . Secure Data Transmission: It adheres to strict security protocols, utilizing HTTPS, AES 256 encryption, and multi-factor authentication (MFA) for secure access.
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