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FDA 510(k)

VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE

K-Number: K032748 · 2003-10-29

ApplicantVital Images, Inc.
Decision Date2003-10-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE 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 2003-10-29 under 510(k) number K032748. 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 3.4 MEDICAL IMAGE PROCESSING SOFTWARE?

VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Vital Images, Inc.. The 510(k) number is K032748.

When did VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE receive FDA 510(k) clearance?

VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE received FDA 510(k) clearance on 2003-10-29, under 510(k) number K032748.

Who is the listed applicant for VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE?

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 3.4 MEDICAL IMAGE PROCESSING SOFTWARE?

The FDA product code for VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE 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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