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510(k) Data Aggregation
K Number
K143703Device Name
NICAL SMART MICRO CR system for intraoral dental images
Manufacturer
NICAL SPA
Date Cleared
2015-03-18
(79 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
NICAL SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
Device Description
The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray 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 the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
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K Number
K053029Device Name
NDR+/DIVA-D
Manufacturer
NICAL SPA
Date Cleared
2006-01-06
(71 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
NICAL SPA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
Device Description
The NICAL NDR+ is a digital image acquisition system to be used in conjunction with an image Intensifier during radiography or fluoroscopy x-ray examination to capture images by a camera, digitalize the image, review images and format images according to DICOM 3.0 protocol to be sent through network connection.
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