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510(k) Data Aggregation
K Number
K151687Device Name
QuantorView
Manufacturer
3DISC AMERICAS
Date Cleared
2015-08-03
(41 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
3DISC AMERICAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quantor View is PACS image viewing software for DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). The software allows physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for viewing, researching, teaching, teleconferencing and online collaboration.
Device Description
This is a PC software product used for viewing digital medical images having the following features: DICOM File Support (Read and display all DICOM files (mono-frame, multi-frame), Read and display non-DICOM file (JPEG Lossy, JPEG Lossless, JPEG2000, RLE), Read and write DICOM CD/DVD (DICOMDIR support), Export DICOM files to BMP, TIFF, JPEG, Convert Non-DICOM images to DICOM, Convert multi-frame image to AVI file), DICOM Network Support (DICOM Storage SCU/SCP, DICOM Query/Retrieve SCU/ SCP, DICOM Print SCU with 8, 12 bit support), Viewer Functions (Customizable toolbars, NN, linear, cubic, super sampling interpolation, ROIs: polygons, circles, rectangles and etc., Custom LUT and curve, CT/MR scout line view, Thumbnail images support, Support 1 to 4 monitors, User defined hanging protocol, tool bar, overlay, Local database support, Local backup support).
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K Number
K133106Device Name
COMPUTED RADIOGRAPHY SCANNER
Manufacturer
3DISC AMERICAS
Date Cleared
2014-01-15
(107 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
3DISC AMERICAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.
Device Description
The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate. X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
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K Number
K133120Device Name
COMPUTED RADIOGRAPHY SCANNER
Manufacturer
3DISC AMERICAS
Date Cleared
2014-01-15
(107 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
3DISC AMERICAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.
Device Description
The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
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K Number
K131442Device Name
FIRECR DENTALIMAGING SYSTEM
Manufacturer
3DISC AMERICAS
Date Cleared
2013-09-06
(109 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
3DISC AMERICAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FireCR Dental imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media
Device Description
The FireCR Dental is Computed Radiography Reader which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (Imaging Plate) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collected and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
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K Number
K102619Device Name
COMPUTED RADDIOGRAPHY SCANNER
Manufacturer
3DISC AMERICAS
Date Cleared
2011-05-13
(242 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
3DISC AMERICAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a Computed Radiography Scanner and intended for use in producing digital X-Ray lmages for general radiography purposes. It comprises of scanner, cassette with reusable imaging plate and workstation software. It scans X-Ray exposed image plate and produces X-Ray lmage in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not approved for the acquisition of mammographic image data.
Device Description
The FireCR is Computed Radiography System which produces the X-ray diagnostic image in digital formation wasn't broutinnal screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat flelding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
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