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510(k) Data Aggregation
K Number
K031013Device Name
INFINTT CO., LTD. STARPACS SYSTEM
Manufacturer
INFINITT COMPANY
Date Cleared
2003-04-17
(17 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INFINITT COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STARPACS ™ is a device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
Device Description
STARPACS ™ is a server-based software application that is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. The system provides online access to patients' current and historical radiological images and relevant examination data and is designed for facilitating the clinical practice of radiologists and physicians. STARPACS ™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM 3.0) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-compliant imaging devices such as CT scanners, MR imager, CR systems, and image viewing workstations.
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