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510(k) Data Aggregation
K Number
K091631Device Name
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW
Manufacturer
Date Cleared
2010-03-18
(288 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ASPYRA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aspyra AccessNET PACS is a software device designed to operate on specified off-the-shelf hardware and virtual environments. The device is intended to receive digital images and data from various sources including CT scanners, MR scanners, Nuclear Medicine (NM), PET, ultrasound systems, Computed & Direct radiographic devices (CR, DR), secondary capture devices, scanners, imaging gateways, etc. as well as other DICOM compliant modalities. Images and data can be captured, stored, communicated, processed, printed, and displayed within the system and or across computer networks at distributed locations.
Display and processing functions while viewing images include, but are not limited to, adjustment of window and level, rotation, zoom, measurement of anatomical structures, image stitching, image stacking, filtration of color images (e.g. removal of red channel), annotation and measurement of regions of interest, inversion, rotation, flips, Multi-Planar Reformation (MPR), and Maximum intensity projection (MIP). In addition, users can dictate, edit, sign, and print reports.
The Aspyra AccessNET PACS is indicated for the primary review of "For Presentation" DICOM mammographic images. Lossy compressed mammographic images and digitized film screen images must not be used for primary image interpretations. Mammographic images for primary image interpretations may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
The Aspyra PACS is a system used for the management of clinical images and reports. It provides Picture Archive and Communications System (PACS) functionality as well as management of clinical workflow.
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