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510(k) Data Aggregation
K Number
K073670Device Name
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
Manufacturer
OREX COMPUTED RADIOGRAPHY LTD
Date Cleared
2008-01-25
(29 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
OREX COMPUTED RADIOGRAPHY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.
The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.
Device Description
Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.
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K Number
K032654Device Name
PORT CASSETTE
Manufacturer
OREX COMPUTED RADIOGRAPHY LTD
Date Cleared
2003-10-09
(42 days)
Product Code
IXK
Regulation Number
892.1630Why did this record match?
Applicant Name (Manufacturer) :
OREX COMPUTED RADIOGRAPHY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).
Device Description
The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.
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K Number
K003256Device Name
PCCR DIGITAL IMAGING DEVICE
Manufacturer
OREX COMPUTED RADIOGRAPHY LTD
Date Cleared
2000-11-08
(22 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
OREX COMPUTED RADIOGRAPHY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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