(11 days)
The IMTEC Imaging ILUMA™ OrthoCat™ and DentalCat™ are x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support.
x-ray devices (cone beam computed tomography) that acquire a single 360° rotational sequence
The provided text is a 510(k) clearance letter from the FDA for the ILUMA OrthoCat/DentalCat device. This document primarily focuses on the regulatory approval process and does not contain the specific details about acceptance criteria, study design, or performance metrics that would typically be found in a study report or a more detailed section of a 510(k) submission.
Therefore, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets those criteria from the provided text. The document confirms that the device is substantially equivalent to a predicate device but does not elaborate on the specific performance studies conducted to demonstrate this equivalence in terms of detailed metrics, sample sizes, ground truth establishment, or expert reviews.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.