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K Number
K120753
Device Name
CLARISCT
Manufacturer
ICRCO INC.
Date Cleared
2012-07-26

(135 days)

Product Code
OAS
Regulation Number
892.1750
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings ...

Device Description

The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings ...

AI/ML Overview

This document is a 510(k) clearance letter for the Claris CBCT device. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, it does not contain the acceptance criteria or the study data that proves the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative letter from the FDA, confirming clearance, and does not delve into the technical validation of the device's performance against specific acceptance criteria.

§ 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.