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510(k) Data Aggregation
K Number
K222666Device Name
X-View 3D Pan/X-View 2D Pan
Manufacturer
Trident s.r.l
Date Cleared
2023-07-10
(307 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Trident s.r.l
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-View 3D PAN/X-View 2D PAN panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of examined volume for the reconstruction of 3D view. The X-View 3D PAN/X-View 2D PAN dental panoramic and cephalometric device is intended for general populations as long as they are older than 10 years.
The device must only be operated and used by dentists and other legally qualified professionals.
Device Description
The X-View PAN is manufactured by Trident s.r.l. and it can be sold under two different commercial names:
- X-View 3D PAN
- X-View 2D PAN
Both devices, depending on the configuration chosen, can be equipped with a cephalometric arm equipped with a 24x30 cm flat panel sensor for the execution of cephalometric radiographs of various formats and latero-lateral and antero-posterior projections. The cephalometric device can also be added in the field.
The device can be set in the configurations: Floor version with column and wall bracket and Floor version with column and standard base.
The subject dental X-ray system X-View is supported by software (firmware). The software is of Moderate Level of concern and is FDA-cleared.
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K Number
K200625Device Name
I-View Gold and Imagen Gold Dental Sensors
Manufacturer
Trident s.r.l
Date Cleared
2020-04-15
(36 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Trident s.r.l
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-View Gold sensors are digital dental intraoral sensors intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Device Description
The subject I-View Gold and Imagen Gold sensors are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port: and (2) an Image Management Software package.
The subject comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm² and two brand names.
Direct digital systems acquire images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure.
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K Number
K182206Device Name
RiX70 DC
Manufacturer
Trident s.r.l
Date Cleared
2018-09-13
(29 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Trident s.r.l
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RiX70 DC X-ray Unit is designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.
Device Description
The subject device is RiX70 DC X-rav Unit and it is an extraoral source dental x-ray system intended for intraoral imaging. The subject device is a device comprised of a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively:
- A control unit equipped with wall plate, extension arm and wired control . device.
- A tube head with x-ray tube.
X-ravs are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology. X-rav emission at 70 kV and 7 mA (maximum power), and the xray unit automatically calculates the best exposure time (from 0.01 s to 2.00 s) based on the selected tooth and patient size, as well as an adjustable arm that allows for easy positioning. This device may also be adjusted manually to the user's specific radiographic technique.
The system can be used either with conventional film or a digital imaging system.
The RiX70 DC is available in two configurations: a wall-mount configuration and a floor-standing configuration, and provides for three selections of kVp: 60kVp, 65kVp, and 70kVp.
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K Number
K162619Device Name
I View and Imagen Sensor
Manufacturer
TRIDENT S.R.L.
Date Cleared
2016-11-04
(45 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
TRIDENT S.R.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-View dental sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Device Description
The subject device I View is an intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
The Size 1 sensor is also known as factory code S11684-12; Size 2 sensor is known as factory code S116845-12. I View and Imagen Sensor will both have Size 1 and Size 2. Two different trade names are for marketing purposes.
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K Number
K160386Device Name
ReadeR, VieweR, QuickScan PSP
Manufacturer
TRIDENT S.R.L
Date Cleared
2016-03-10
(28 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
TRIDENT S.R.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ReadeR is a dental imaging system indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
ReadeR system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.
Device Description
The ReadeR is a computer radiography system which produces the x-ray diagnostic image in digital format instead of using traditional screens and film. This device does not have a wireless transmission. The 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 plates 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 and offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, the 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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