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FDA 510(k)

BIO-RAY SDX DIGITAL X-RAY SYSTEM

K-Number: K060179 · 2006-02-08

ApplicantSigma Biomedics, Inc.
Decision Date2006-02-08
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-RAY SDX DIGITAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Biomedics, Inc.. It received FDA 510(k) clearance on 2006-02-08 under 510(k) number K060179. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-RAY SDX DIGITAL X-RAY SYSTEM?

BIO-RAY SDX DIGITAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-08. The listed applicant is Sigma Biomedics, Inc.. The 510(k) number is K060179.

When did BIO-RAY SDX DIGITAL X-RAY SYSTEM receive FDA 510(k) clearance?

BIO-RAY SDX DIGITAL X-RAY SYSTEM received FDA 510(k) clearance on 2006-02-08, under 510(k) number K060179.

Who is the listed applicant for BIO-RAY SDX DIGITAL X-RAY SYSTEM?

The FDA 510(k) record lists Sigma Biomedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-RAY SDX DIGITAL X-RAY SYSTEM?

The FDA product code for BIO-RAY SDX DIGITAL X-RAY SYSTEM is MUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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