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510(k) Data Aggregation
K Number
K052661Device Name
QUIX DIGITAL RADIOGRAPHIC UPGRADE
Manufacturer
Date Cleared
2006-06-07
(253 days)
Product Code
Regulation Number
892.1680Why did this record match?
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Matched: '892.1840'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Quix Digital Radiography Upgrade is based on a solid state imaging device and is intended for use in general radiographic examinations and applications wherever conventional film-screen systems may be used, excluding mammography, fluoroscopy, and angiography.
Device Description
The Quix Digital Radiography Upgrade enables a conventional film-screen X-ray system to perform digital radiography exams by replacing the film-screen and the film-screen bucky with a digital bucky and operator console. The digital bucky incorporates a selenium-based flat panel detector with 16" x 17" imaging area. Images are displayed in approximately 10 seconds after exposure over a wide range of dose settings. The operator console provides local image storage and communicates with other network devices using DICOM 3.0 protocols.
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K Number
K013999Device Name
LODOX, MODEL BASELINE
Manufacturer
Date Cleared
2002-08-06
(245 days)
Regulation Number
892.1750Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.
Device Description
Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image. The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing. The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.
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K Number
K992955Device Name
XPLORER 1000
Manufacturer
Date Cleared
2000-06-02
(275 days)
Product Code
Regulation Number
892.1680Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863. Not to be used for mammography.
Device Description
The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.
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K Number
K981556Device Name
CANON X-RAY DIGITAL CAMERA CXDI-11
Manufacturer
Date Cleared
1998-11-04
(187 days)
Product Code
Regulation Number
892.1680Why did this record match?
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Matched: '892.1840'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
CANON X-RAY DIGITAL CAMERA CXDI-11 provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
Device Description
CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device is used to capture the image in electronic form. The digital data are then used to produce diagnostic hardcopy and reference-softcopy images.
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K Number
K973206Device Name
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
Manufacturer
Date Cleared
1997-12-04
(100 days)
Product Code
Regulation Number
892.1680Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Direct Radiography™ device provides a digital image capture capability for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The device has application wherever conventional screen-film systems are currently used.
Device Description
The Sterling Diagnostic Imaging Direct RadiographyTM device is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for diagnostic viewing and printing. The device provides digital image capture for conventional radiographic examinations (excluding fluoroscopic, angiographic, and mammographic applications). The Direct RadiographyTM device differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device called a digital array is used to capture the image in electronic form. The digital data are then used to produce hardcopy and softcopy images.
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