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510(k) Data Aggregation
K Number
K092134Device Name
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
Manufacturer
STATRAD, LLC
Date Cleared
2009-09-15
(62 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
STATRAD, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StatPacs™ is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM allowing StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatView™ with the Exam Manager™ application, is a primary user interface for processing of medical images for primary image diagnosis. Image compression and encryption adhere to standard industry protocol. StatPacs™, is not to be used for mammography imaging.
Device Description
The StatPacs™ is a software based PACS product, intended to be used by radiologists technologists and clinicians, to operate on specified off the shelf hardware (OTS) that will provide teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis. Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.
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