(260 days)
The NAOMI-DPX D100 is indicated for use in acquiring Panoramic radiographic images at the dento-maxillofacial region. The image generated is displayed on a computer monitor. It is intended to replace radiographic film/screen system in dental diagnostic procedures
The NAOMI-DPX-D100 provided digital image capture for conventional film/screen systems. It is intended to replace the radiographic film/screen systems.
The x-ray photons incident to the NAOMI-DPX-D100 are detected and converted into the light photons at the scintillator. The light photons are detected and converted into the electrical signal at the CCD. NAOMI-DPX software captures and displays the image.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a Digital X-Ray Imaging System (NAOMI-DPX-D100), primarily focusing on its general information, device description, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Specifically, the document states:
- Comparison to predicate: "The performance data demonstrate that NAOMI-DPX-D100 is as safe and effective as the predicate devices (CDR-PAN MODEL4700, Signet DXIS and DIGIPAN DPI)."
- Conclusion: "It is opinion of RF Co.,Ltd. strongly believe that the NAOMI-DPX-D100 described in this submission is substantially equivalence to predicate device (NAOMI)."
This indicates that the device's performance was compared to predicate devices for substantial equivalence, but it does not detail specific acceptance criteria, the study design, or the results that would allow for filling out the requested table and answering the subsequent questions. The document mainly highlights that the device is intended to replace conventional film/screen systems and its specifications are "the same or better than NAOMI" (a previous version from the same manufacturer).
Therefore, I cannot provide the requested information.
§ 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.