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510(k) Data Aggregation
K Number
K062488Device Name
IQ-SYSTEM PACS SYSTEM
Manufacturer
IMAGE INFORMATION SYSTEMS, LTD.
Date Cleared
2006-09-19
(25 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IMAGE INFORMATION SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iQ-System PACS is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Device Description
iQ-System PACS is a software device for network or web-based medical image viewing and manipulation, running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. iQ-System PACS fully supports the DICOM standard and has functionality for advanced DICOM viewing, Hanging Protocol, and 3D image processing (Orthogonal and Oblique Multiplanar Reconstructions (MPR), Maximum Intensity Projections (MIP), Surface Shaded Display (SSD), and Volume Rendering (VRT)). The main iQ-SYSTEM PACS modules are iQ-LITE, iQ-Print, iQ-View (including iQ-3D), and iQ-Web.
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