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Bio-Ray Sdx Digital X-Ray System

by Sigma Biomedics, Inc.

510(k) K060179

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060179 Date8 Feb 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUH
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bio-Ray Sdx Digital X-Ray System is an extraoral source digital X-ray system designed for dental applications. It functions to capture dental X-ray images for diagnostic purposes.

This device is authorized under FDA 510(k) clearance. No further information regarding its sterility, single-use status, or MRI safety is provided in the available data.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Bio-Ray Sdx?

    The Bio-Ray Sdx is an extraoral source digital X-ray system specifically designed for dental applications. Its primary function is to capture high-quality dental X-ray images to assist clinicians with diagnostic purposes.

  • What is the regulatory status of this device?

    The Bio-Ray Sdx Digital X-Ray System is authorized under FDA 510(k) clearance. This indicates that the manufacturer has demonstrated the device is substantially equivalent to a legally marketed predicate device.

  • Are there specific instructions regarding the sterility or single-use status of this system?

    The provided technical data for the Bio-Ray Sdx does not contain information regarding sterility requirements or single-use status. Users should refer to the manufacturer-provided labeling and user manual for specific maintenance and operational protocols.