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510(k) Data Aggregation
K Number
K052938Device Name
CR-PRO
Manufacturer
ERADLINK, INC.
Date Cleared
2005-11-17
(28 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ERADLINK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CR-Pro is a free standing, laser driven, image digitizer intended to produce digital copies of phosphor plate recorded images in 16 levels of gray scale. The digital copies are transmitted to an internal Intel Pentium 4 based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
This device is not to be used for primary imaging diagnosis in mammography.
Device Description
The eRadlink CR-Pro is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed path of fiber optics. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable.
Phosphor plates from a minimum of 10 inches to a maximum of 14 inches in width, is driven past the digitizing laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the internal computer for processing.
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K Number
K020243Device Name
LASERPRO 16
Manufacturer
ERADLINK, INC.
Date Cleared
2002-03-05
(41 days)
Product Code
LMA, LUM
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
ERADLINK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LaserPro 16 is a desk top laser image digitizer intended to produce digital copies of radiological film in 10 bit gray scale. The digital copies are transmitted to a conventional based personal computer (PC) where they may be transmitted to a PACS (Picture Archiving and Communication System) or other networks to other medical facility sites.
Device Description
The eRadLink LaserPro 16 is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed optic path. There are no internal lenses, mirrors, or electro-optic devices. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable. Film, from a minimum of 2 inches to a maximum of 14 inches in width and, from a minimum of 2 inches to a maximum of over 52 inches in length is driven passed the scanning laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the host computer in DICOM format.
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