Search Results
Found 1 results
510(k) Data Aggregation
K Number
K232552Device Name
TuxDeluxe (Size 1 6100B, Size 2 6101B)
Manufacturer
Tuxedo Imaging LLC
Date Cleared
2023-10-20
(58 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Tuxedo Imaging LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are 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. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.
Device Description
This Intraoral Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human mouth and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and transfers it to a computer through USB connection (Universal Serial Bus). The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device. Device sensor sizes: Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm. The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.
Ask a Question
Page 1 of 1