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FDA 510(k)

IMALUX OCT IMAGING SYSTEM

K-Number: K033783 · 2004-03-01

ApplicantImalux Coporation
Decision Date2004-03-01
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMALUX OCT IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imalux Coporation. It received FDA 510(k) clearance on 2004-03-01 under 510(k) number K033783. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMALUX OCT IMAGING SYSTEM?

IMALUX OCT IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-01. The listed applicant is Imalux Coporation. The 510(k) number is K033783.

When did IMALUX OCT IMAGING SYSTEM receive FDA 510(k) clearance?

IMALUX OCT IMAGING SYSTEM received FDA 510(k) clearance on 2004-03-01, under 510(k) number K033783.

Who is the listed applicant for IMALUX OCT IMAGING SYSTEM?

The FDA 510(k) record lists Imalux Coporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMALUX OCT IMAGING SYSTEM?

The FDA product code for IMALUX OCT IMAGING SYSTEM is NQQ.

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Related Devices (Code: NQQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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