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510(k) Data Aggregation
K Number
K092427Device Name
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
Manufacturer
Date Cleared
2010-03-16
(221 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALBERT DAVYDOV DDS PC PROFESSIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Spinal Guides PACS is intended to perform: operations relating to the acceptance of spinal X-ray medical images and patient demographic information, their display, digital processing, review and editing, measurements report generation with respective storage and teleradiology exchange capabilities. They are intended to be used by a physician to view the images and use as an aid in calculation of alteration of motion segment integrity (AOMSI) of human spine. This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.
Device Description
The device is represented by a software computer program installed on regular computers. The device has two types of users: a web and a local user. The web user submits an image set for processing to the local user via internet to the device's database. The local user is viewing the images of the image set, process the image set and sends a PDF report with calculations for the web user.
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