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FDA 510(k)

BI IMAGE-X EVOLUTION

K-Number: K160458 · 2016-06-20

ApplicantRadiotecnologia Industrial S.A. DE C.V.
Decision Date2016-06-20
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BI IMAGE-X EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Radiotecnologia Industrial S.A. DE C.V.. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K160458. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI IMAGE-X EVOLUTION?

BI IMAGE-X EVOLUTION is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Radiotecnologia Industrial S.A. DE C.V.. The 510(k) number is K160458.

When did BI IMAGE-X EVOLUTION receive FDA 510(k) clearance?

BI IMAGE-X EVOLUTION received FDA 510(k) clearance on 2016-06-20, under 510(k) number K160458.

Who is the listed applicant for BI IMAGE-X EVOLUTION?

The FDA 510(k) record lists Radiotecnologia Industrial S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BI IMAGE-X EVOLUTION?

The FDA product code for BI IMAGE-X EVOLUTION is EHD.

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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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