# K133206: Z-Ray Intra-Oral Digital Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Zuma Dental, LLC
- Decided: May 13, 2014 after 208 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.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072134: Schick Computed Oral Radiology System, Schick Technologies, Inc. (2007) Summary page 1.
- K090458: Dexis Sensor, Dexis, LLC (2009) Summary page 1.

## Indications for use
The Z-Ray digital radiography system was designed for the sole purpose of capturing radiographic images of teeth and the surrounding structures limited to the oral cavity. This device should be used under the direction of a licensed Dentist when it is deemed necessary to perform a radiographic series of a patient for diagnostic purposes.

Source page: https://510kreport.com/device/K133206
Methodology: https://510kreport.com/methodology