Jazz Classic
Jazz ImagingJazz Classic is a dental imaging software that helps dental professionals capture, process, store, and review diagnostic dental images from various devices including intraoral x-ray sensors and scanners. It runs on standard PC hardware and assists clinicians in diagnosis and treatment planning by allowing image enhancement, annotation, and secure image management. This software supports both pediatric and general populations and integrates with dental practice management systems for improved workflow.
Intended Use
Jazz Classic is a clinical software application that captures images and data from Jazz intraoral x-ray sensors and various imaging sources. It enables acquisition, display, editing, review, printing, and distribution of images using standard PC hardware for diagnostic and non-diagnostic purposes by dental professionals.
Technology
Jazz Classic is a dental imaging software application that operates on standard PC hardware with connected display or monitor. It acquires digital images from intraoral x-ray sensors, dental panoramic and cephalometric scanners, and intraoral cameras. The software stores images in lossless compression and exports in standard formats (DICOM, PNG, JPEG, TIF). It includes visualization, annotation, and image manipulation tools to aid diagnosis and treatment planning. It integrates with client-server practice management software to utilize patient scheduling and clinical data.
Performance
Verification testing confirmed Jazz Classic met software design requirements. Bench testing demonstrated superior signal-to-noise ratio and resolution compared to the predicate device, validating enhanced image processing capabilities. Clinical evaluation showed the device meets operational and clinical needs for safely acquiring and evaluating dental images by expert opinion.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/28/2024
5 months - 2
FDA Approval
11/21/2024
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