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FDA 510(k)

FIATLUX VISUALIZE

K-Number: K082041 · 2008-08-01

ApplicantFiatlux Imaging, Inc.
Decision Date2008-08-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FIATLUX VISUALIZE is the device name listed in this FDA 510(k) record. The listed applicant is Fiatlux Imaging, Inc.. It received FDA 510(k) clearance on 2008-08-01 under 510(k) number K082041. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIATLUX VISUALIZE?

FIATLUX VISUALIZE is a medical device that received FDA 510(k) clearance on 2008-08-01. The listed applicant is Fiatlux Imaging, Inc.. The 510(k) number is K082041.

When did FIATLUX VISUALIZE receive FDA 510(k) clearance?

FIATLUX VISUALIZE received FDA 510(k) clearance on 2008-08-01, under 510(k) number K082041.

Who is the listed applicant for FIATLUX VISUALIZE?

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

What is the FDA product code for FIATLUX VISUALIZE?

The FDA product code for FIATLUX VISUALIZE is LLZ.

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Official Source

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

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