# K213637: JAZZ Solo sensor

- Pathway: 510(k) (Special)
- Applicant: Jazz Imaging, LLC Dba Jazz Imaging
- Decided: Dec 10, 2021 after 22 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: 5 generations back to K933455 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163224: JAZZ SOLO Sensor, Jazz Imaging, LLC (2017) Summary page 4.

## Indications for use
JAZZ Solo sensor is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images that can be displayed, enhanced, printed, and saved.

Source page: https://510kreport.com/device/K213637
Methodology: https://510kreport.com/methodology