# K060179: Bio-Ray SDX  Digital  X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Biomedics, Inc.
- Decided: Feb 8, 2006 after 16 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the teeth, jaw and oral structures with the use of computer imaging software provided by other 3rd parties, readily available from numerous sources. This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors.

Source page: https://510kreport.com/device/K060179
Methodology: https://510kreport.com/methodology