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510(k) Data Aggregation
K Number
K231660Device Name
Digital image scanner of dental
Manufacturer
Jiangsu Dynamic Medical Technology Co., Ltd.
Date Cleared
2023-12-20
(196 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Dynamic Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Digital image scanner of dental is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.
Device Description
Digital image scanner of dental is a dental device that scans IP Imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on the screen and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size S0, S1, S2 and S3. The intraoral plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with 630-645 nm laser. The laser beam is moved across the surface of the plate by an oscillating mirror. The laser beam stimulates the top coating of the plates, which consists of X-rays sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier tube/ PMT) and transferred into an electrical output signal. This signal is digitalized and is the data for the digital X-ray image. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the screen, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.
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