ZeTTA PACS
Tae Young Soft Co., Ltd.ZeTTA PACS is a software system designed for hospitals and diagnostic centers to receive, store, retrieve, and display medical images from various modalities such as CT, MRI, ultrasound, and X-ray. It helps healthcare professionals securely access and analyze diagnostic images over hospital networks, supporting efficient image interpretation and management but does not provide diagnostic decision-making functions.
Intended Use
ZeTTA PACS is intended for use in hospitals and diagnostic centers as a PACS to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices. The system enables healthcare professionals to securely access and analyze diagnostic images over hospital networks.
Technology
ZeTTA PACS is a Windows-based Picture Archiving and Communication System (PACS) that supports DICOM 3.0 standard, enables multi-monitor high-resolution image viewing, multi-worklist functionality, image analysis tools (ruler, angle), image manipulation (windowing, zoom), and integrates multiple imaging sources into a centralized solution over hospital networks.
Performance
Software was designed and validated according to FDA guidance for device software functions. Performance tests confirmed all functions work without errors, and device performance is equivalent to the predicate device. No clinical studies were performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/12/2024
7 months - 2
FDA Approval
1/31/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.