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FDA 510(k)

VITREA2 VERSION 3.8.1

K-Number: K060378 · 2006-03-09

ApplicantVital Images, Inc.
Decision Date2006-03-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREA2 VERSION 3.8.1 is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2006-03-09 under 510(k) number K060378. 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 VITREA2 VERSION 3.8.1?

VITREA2 VERSION 3.8.1 is a medical device that received FDA 510(k) clearance on 2006-03-09. The listed applicant is Vital Images, Inc.. The 510(k) number is K060378.

When did VITREA2 VERSION 3.8.1 receive FDA 510(k) clearance?

VITREA2 VERSION 3.8.1 received FDA 510(k) clearance on 2006-03-09, under 510(k) number K060378.

Who is the listed applicant for VITREA2 VERSION 3.8.1?

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

What is the FDA product code for VITREA2 VERSION 3.8.1?

The FDA product code for VITREA2 VERSION 3.8.1 is LLZ.

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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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