K-numberK241694
Device nameZeTTA PACS
ApplicantTae Young Soft Co., Ltd.
Product codeLLZ
Device classClass II
Decision dateJan 31, 2025
DecisionSubstantially Equivalent
Regulation892.2050
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

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.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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