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510(k) Data Aggregation
K Number
K081948Device Name
RAYPAX SYSTEM
Manufacturer
Date Cleared
2008-09-19
(73 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RAYPAX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RAYPAX System is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images acquired from devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Film Scanners, and any other DICOM supporting devices.
The clients of RAYPAX System are intended for diagnostic and analysis tool by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. QCW(Quality control Workstation) is intended for technicians to verify exams. DW(Diagnostic Workstation) and RW(Review Workstation) is intended for radiologists to perform a diagnostic analysis of the exams and WCC(Web Client Component) is intended for the clinical review of physicians. Net Point and Lite are intended to acquire exams from remote facilities through the Internet. Net, Exp and Web client versions are intended for a remote access to the images through the Internet.
For the digital mammography images, to be viewed for primary interpretation, images must be acquired from an FDA approved Mammography device for primary interpretation and viewed on a display system with at least 5 Mega Pixel of resolution and has been cleared by the FDA for diagnosis of digital mammography images. Furthermore, the Mammography device must be able to provide, to the RAYPAX System, a viewable DICOM 'for presentation' mammography image. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
Device Description
The RAYPAX System is a complete PACS package to receive medical images from medical modalities, and distribute medical images and reports to enable medical staff to verify, diagnosis, and refer them in multi medical facilities. It consists of RAYPAX PACS server, Getaways and Clients.
RAYPAX PACS server stores the images and information obtained from the medical equipments and other systems, and provides a connection for RAYPAX client to access the information depending on their previledge level. Remote access through the Internet is allowed, and to ensure a secure data transfer, strong data encryption(SSL) is provided. All DICOM images acquired in the RAYPAX System are stored unaltered and all display manipulations and annotations are stored as presentation parameters and they do not alter the original image file.
RAYPAX Gateways communicate with medical modalities and other systems to receive and share image data, patient demographics, order schedule and study results. DICOM Gateway gathers medical exams from modalities and other system in DICOM format. Remote exams are gathered by Net Point or Lite locally and sent to PACS server through the internet. HL7 Gateway exchanges the patient and order information, study results with other information system in HL7 standard.
The clients of RAYPAX System are intended for diagnostic and analysis by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. RAYPAX Clients connect the PACS server and enables medical staff to view medical data and assign special tasks in the PACS workflow.
OCW is a verification tool for a technician to reconstruct, verify exams. DW (Diagnostic Workstation) and RW (Review Workstation) are for the radiologist to perform diagnostic analysis of the exams. TW (Transcription Workstation) is a tool for the trancriptionist to create a preliminary report. WCC (Web Client Component) is a radiology referring tool for a physican to refer exam and report viewing at remote site. Net, Exp and Web versions of RAYPAX clients are intended to offer a remote access to the images through the Internet.
For PACS administrators, Admin provides with user management, server parameter setting, and Net Monitor provides the status of the PACS system and the performance of the medical organization.
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