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510(k) Data Aggregation
K Number
K973959Device Name
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
Manufacturer
OLICON IMAGING SYSTEMS, INC.
Date Cleared
1997-12-22
(67 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
OLICON IMAGING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olicon 02-Workstation and/or PACSView™ Software is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images/data can be stored, communicated, processed, and displayed within the workstation and or across computer networks at distributed locations.
Device Description
The Olicon 02-Workstation and/or PACSView™ software is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which is used to store, communicate, and view radiological images and data in a digital format. Images are stored and displayed utilizing Intel Pentium processing unit with high resolution monitors.
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K Number
K973793Device Name
OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE
Manufacturer
OLICON IMAGING SYSTEMS, INC.
Date Cleared
1997-12-17
(72 days)
Product Code
LMD
Regulation Number
892.2020Why did this record match?
Applicant Name (Manufacturer) :
OLICON IMAGING SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).
The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical technicians.
Device Description
The Olicon Gateway system is a general purpose computer system consisting of a computer (console, display, keyboard, and mouse) and software which runs a protocol conversion software application that uses defined configuration to receive, reformat, and transmit images and demographic information. The system is capable of receiving images from different sources and routes them automatically to predefined destinations.
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