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510(k) Data Aggregation
K Number
K062878Device Name
EZPACS, VERSION 3.0
Manufacturer
Date Cleared
2007-06-27
(274 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED IMAGING SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
EZPACS® is a PACS system that runs on off-the-shelf monitors and PCs running the Microsoft Windows® operating system. It consists of software that displays images and provides functions for image manipulation, enhancement, compression and quantification.
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