# K163224: JAZZ SOLO Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Jazz Imaging, LLC
- Decided: Mar 9, 2017 after 113 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933455 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090458: Dexis Sensor, Dexis, LLC (2009) Summary page 4.

## Most influential descendants
- K213637: JAZZ Solo sensor (2021), 0 descendants of its own

## Indications for use
The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.

Source page: https://510kreport.com/device/K163224
Methodology: https://510kreport.com/methodology