QuickRad
Aikenist Technologies Pvt LtdQuickRad is a web-based PACS (Picture Archiving and Communication System) designed for radiology centers and hospitals. It manages and displays medical images from various scanners including CT, MRI, ultrasound, and X-ray, and allows users to integrate FDA-cleared AI models to assist radiologists by visualizing AI outputs alongside images. This helps clinicians by improving workflow efficiency and providing advanced image viewing and reporting tools.
Intended Use
QuickRad is a web-based PACS intended for use in radiology centers, diagnostic labs, and hospitals 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. It also optionally integrates with FDA-cleared third-party AI models to display AI-generated outputs 'as-is'.
Technology
QuickRad is a web-based PACS with a zero footprint viewer compatible with multiple operating systems and browsers, supporting true-to-source image fidelity and advanced 3D visualization such as MPR and MIP. It integrates optional FDA-cleared third-party AI models displaying outputs alongside original images. It adheres to DICOM standards and uses HTTPS, AES 256 encryption, and multi-factor authentication for secure access.
Performance
QuickRad underwent comprehensive non-clinical performance testing including risk management per ISO 14971, security vulnerability assessments, usability testing per IEC 62366-1, software verification and validation (unit, integration, system, and user acceptance testing), and measurement accuracy studies showing equivalence to an FDA-cleared viewer. AI integration interfaces were tested to ensure data integrity.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/19/2024
5 months - 2
FDA Approval
2/21/2025
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