FDA 510(k)

OPAL-RAD

K-Number: K063337 · 2006-12-12

Decision Date2006-12-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OPAL-RAD is the device name listed in this FDA 510(k) record. The listed applicant is Viztek, Inc.. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K063337. 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 OPAL-RAD?

OPAL-RAD is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Viztek, Inc.. The 510(k) number is K063337.

When did OPAL-RAD receive FDA 510(k) clearance?

OPAL-RAD received FDA 510(k) clearance on 2006-12-12, under 510(k) number K063337.

Who is the listed applicant for OPAL-RAD?

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

What is the FDA product code for OPAL-RAD?

The FDA product code for OPAL-RAD is LLZ.

Other records listing Viztek, 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.

K102123VIZION DR K091752VIZTEK WL K082604VIZTEK DR, MODELS: DR1000, DR3000, DR4000 K003607ONYX-RAD TELEMEDICINE PACS

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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.