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510(k) Data Aggregation
K Number
K220277Device Name
Digital Intraoral X-ray Sensor
Manufacturer
Shenzhen Xpectvision Technology Co.,Ltd.
Date Cleared
2022-02-17
(17 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Xpectvision Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The digital intraoral X-ray sensors XVD2121 Plus, XVD2530 are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. Each can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.
Device Description
The subject device digital intraoral X-ray sensor, XVD2121 Plus or XVD2530, is used as X-ray receptor to acquire dental X-ray radiographic images in clinical entities. The subject device doesn't emit X-rays. The X-rays are to be generated from X-ray dental machine, a separate device. The subject device can be used by trained dental professionals for patients receiving intraoral X-ray imaging examinations and produces digital images that can be displayed, and archived digitally. To acquire X-ray intraoral radiographic image, first the X-rays are to be generated from the X-ray dental machine and passing through human teeth and surrounding anatomy; then the attenuated X-ray beams are detected by the sensor and subsequently converted into digital data that are to be transmitted to the software (computer). The imaging data are then stored in DICOM format images that can be displayed on the monitor and viewed by dentists.
The subject device digital intraoral X-ray sensor consists of sensor, adaptor, cable, and software (computer or laptop NOT part of the device).
The intraoral sensor detects the incident X-rays and converts X-rays into digital signal or data. The sensor consists of tiny silicon chip-based pixels and their associated electronics encased in a plastic housing. The intraoral sensor is small, thin, flat, rigid rectangular box, usually black in color and similar in size to intraoral film packets. Sensors vary in thickness from about 5 to 7 mm. Sensor is cabled to allow data to be transferred directly from the mouth to the computer (software) via the USB port.
When used clinically the sensor shall be covered with a protective plastic barrier envelope for infection control purposes. New sheath is required for each new patient and must be disposed of after patient use. One usually slide the sensor into the sheath to provide a secure barrier around the sensor. The protective cover sheath is disposable and is a separate device, NOT a part of this device.
To acquire the intraoral X-ray radiographic images, the sensor (with sheath) is placed inside the mouth as X-ray receptor. First the X-rays are to be generated from the dental X-ray generating machine outside of the mouth. The X-rays pass through and are attenuated by tooth/teeth and surrounding anatomy; the attenuated X-rays are detected by the sensor and then converted into digital data that are to be transmitted to the software (computer).
The digital data are then stored in DICOM format image that can be displayed on the monitor and viewed by dentists. The key clinical feature of intraoral sensor is the rapid availability of the image after exposure. The sensor is utilized as X-ray receptor, and does NOT emit X-rays. The X-ray generating equipment is a separate device. NOT a part of subject device.
The physical size of model XVD2530 is 31.5mm * 38.5mm, while that of model XVD2121 Plus is 26.5mm * 32mm. The effective imaging area of model XVD2530 is 29.5mm * 24.6mm, while that of model XVD2121 Plus is 20.0mm * 19.8mm. The differences between model XVD2121 Plus and model XVD2530 are the physical sizes and effective imaging areas. Otherwise model XVD2121 Plus and model XVD2530 are exactly same device. Different size is offered to better fit with size of oral cavity of individual patient and different anatomic region, such as posterior teeth or anterior teeth.
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