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FDA 510(k)

VITREAADVANCED

K-Number: K121213 · 2012-11-02

ApplicantVital Images, Inc.
Decision Date2012-11-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREAADVANCED 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 2012-11-02 under 510(k) number K121213. 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 VITREAADVANCED?

VITREAADVANCED is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is Vital Images, Inc.. The 510(k) number is K121213.

When did VITREAADVANCED receive FDA 510(k) clearance?

VITREAADVANCED received FDA 510(k) clearance on 2012-11-02, under 510(k) number K121213.

Who is the listed applicant for VITREAADVANCED?

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 VITREAADVANCED?

The FDA product code for VITREAADVANCED 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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