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510(k) Data Aggregation
K Number
K051649Device Name
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
Manufacturer
CAMTRONICS MEDICAL SYSTEMS
Date Cleared
2005-08-02
(42 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CAMTRONICS MEDICAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician-generated clinical reports (via structure reporting and template based tools), and to store this information in a database.
· VERICIS is software comprised of modules that perform under standard "offthe-shelf" personal computers and servers running the Microsoft Windows 2000/2003/XP operating systems.
• VERICIS is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to HL7 and XML.
• VERICIS is an Internet/Intranet network system that is designed for small and large, multi-user environments. The VERICIS network structure (including server and workstations) provides for the system's database management, storage, printing, and all DICOM/HL-7 interface services.
Device Description
The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system. The VERICIS is a modification of the Camtronics Analytical Review Station (K955519) and the Echocardiography System (K992259) to accept multiple modalities. The VERICIS combines modular software applications and third party "off-the-shell" software on standard computer workstations and servers running the specified Microsoft Windows operating systems.
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