# K241495: Jazz Classic

- Pathway: 510(k) (Traditional)
- Applicant: Jazz Imaging
- Decided: Nov 21, 2024 after 177 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930527 (1993). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110886: Clio/Cliosoft, Sota Precision Optics, Inc. (2011) Summary page 5.

## Indications for use
Jazz Classic is a clinical software application that captures images and data from Jazz intraoral x-ray sensors and various imaging sources (e.g., radiographic devices, digital still/video capture devices, and generic image devices such as scanners). Jazz Classic enables the storage of images, clinical notes, and clinical exam data. Jazz Classic is intended to be used for general populations which includes use for pediatric populations. It is intended to acquire, display, edit (e.g., resize, enhance), review, print, and distribute images using standard PC hardware. Jazz Classic is intended for diagnostic and non-diagnostic purposes by dental professionals trained to provide dental care.

Source page: https://510kreport.com/device/K241495
Methodology: https://510kreport.com/methodology