(103 days)
The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.
The Tio-h Digital Radiography Sensor is a digital radiography imaging system. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen.
This FDA 510(k) clearance letter for the "Tio-h Digital Radiography Sensor" (K153144) does not contain information about acceptance criteria, device performance tables, study details like sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on:
- Substantial Equivalence Determination: Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Stating how the device is intended to be used (for basic dental intra-oral x-ray imaging by qualified dental and healthcare professionals).
- Regulatory Information: Details about regulatory classification, applicable regulations, and responsibilities.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or study details using only the provided text. This information would typically be found in a separate section of the 510(k) submission, such as a performance testing summary or clinical study report, which is not part of this specific clearance letter.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.