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FDA 510(k)

Z3D CONTRAST ACUITY

K-Number: K080196 · 2008-09-05

ApplicantClario Medical Imaging, Inc.
Decision Date2008-09-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Z3D CONTRAST ACUITY is the device name listed in this FDA 510(k) record. The listed applicant is Clario Medical Imaging, Inc.. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K080196. 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 Z3D CONTRAST ACUITY?

Z3D CONTRAST ACUITY is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Clario Medical Imaging, Inc.. The 510(k) number is K080196.

When did Z3D CONTRAST ACUITY receive FDA 510(k) clearance?

Z3D CONTRAST ACUITY received FDA 510(k) clearance on 2008-09-05, under 510(k) number K080196.

Who is the listed applicant for Z3D CONTRAST ACUITY?

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

What is the FDA product code for Z3D CONTRAST ACUITY?

The FDA product code for Z3D CONTRAST ACUITY is LLZ.

Related Clinical Trials

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Other records listing Clario Medical Imaging, Inc. as applicant

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.

K052963MEDIQ VERSION 1.0

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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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