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510(k) Data Aggregation
K Number
K964274Device Name
WRITESTAR, AND VIEWSTAR
Manufacturer
COMVIEW CORP.
Date Cleared
1997-01-10
(77 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
COMVIEW CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WriteStar is designed to create convenient and efficient storage, display, and analysis of digital images of heart catheterization and other coronary procedures involving cine-film applications. The WriteStar is designed to support the cine-less cath lab environment and is meant to replace 35mm cine film, and cine projectors currently being used by the majority of cardiac catheterization laboratories. Cine film is currently being used as the permanent archival media for images acquired during heart catheterization. The WriteStar is able to function as an independent unit that accepts images from any imaging system an RS-170 video source.
The ViewStar is a review station. The ViewStar does not have the WriteStan's capability to record to a CD-R disk. The ViewStar can only read (view) a case study from a DICOM compliant CD-R disk.
The ViewStar/Write Star is able to review patient images from A CD-R disk that was previously recorded from an imaging device that uses the DICOM standard. The patient images are transferred from the CD-R disk to the internal hard disk of the WriteStar. Once the images are on the hard disk, the Cardiologist, or other qualified personnel, has the same means to review and analyze images. Analysis is provided via 3rd party industry standard software.
Device Description
The WriteStar is an independent computerized system used in the cardiac catherization laboratories for managing, displaying, and analyzing digitized xray images. It has the following major components(minimally):
- IBM compatible 486/586/ or Pentium computer.
- A SVGA monitor
- HP compatible laser jet printer.
- CD-ROM/CD-R disk
- Software program developed by ComView to run on the IBM OS/2 V3.0 or higher platform.
The archival/review is designed as an accessory to legally marketed medical devices that can digitize x-ray images in the cardiac cath lab. The WriteStar provides image digitization, archival, display, and exchange media compliant to the DICOM standard. The ViewStar provides image review and analysis capabilities and retrieval of data from CD-R disc.
The WriteStar interfaces with commercially available devices that digitize and/or process cine images and or fluoro images and records these images on a 2GB or 4GB SCSI hard drives. These images are simultaneously displayed on the system console for image quality verficication.
Images are acquired from the source device via RS-170 interface. The images are then displayed for review and analysis similar to a cine film projector. As in the cine film projector, the WriteStar will display cine images of a particular patient without the use of film.
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