| K-number | K241694 |
| Device name | ZeTTA PACS |
| Applicant | Tae Young Soft Co., Ltd. |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Jan 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
ZeTTA PACS is a Windows-based Picture Archiving and Communication System designed for hospitals and diagnostic centers to receive, store, retrieve, and display medical images from DICOM-compliant modalities including CT, MRI, ultrasound, and radiographic devices. It enables healthcare professionals to securely access and analyze diagnostic images over hospital networks without providing diagnostic decision-making functions.
ZeTTA PACS supports multiple high-resolution monitors (more than two), provides advanced layout options, multi-worklist functionality, and DICOM GSPS (Grayscale Presentation State). It includes image analysis tools such as ruler and angle measurements, image manipulation features like windowing and zoom, built-in reporting modules, and operates as a standalone Windows-based software module for desktop and workstation environments without mobile device support.
Not stated in this summary.
ZeTTA PACS is substantially equivalent to Infinitt PACS 7.0 because both devices share identical intended use (DICOM-based image management and display in hospitals), identical module architecture (standalone software), identical core functions (study list, worklist modes, image display, reporting, printing to DICOM and paper printers), and comparable feature sets including multi-monitor support, image analysis tools, and DICOM compliance. Performance testing confirmed all functions work without errors and satisfy design intent equivalent to the predicate, with no significant differences that would adversely affect clinical use.
View the full FDA submission: accessdata.fda.gov