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FDA 510(k)

VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM

K-Number: K043333 · 2004-12-15

ApplicantVital Images, Inc.
Decision Date2004-12-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM 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 2004-12-15 under 510(k) number K043333. 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 3.7 MEDICAL IMAGE PROCESSING SYSTEM?

VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-15. The listed applicant is Vital Images, Inc.. The 510(k) number is K043333.

When did VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM receive FDA 510(k) clearance?

VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM received FDA 510(k) clearance on 2004-12-15, under 510(k) number K043333.

Who is the listed applicant for VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM?

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 3.7 MEDICAL IMAGE PROCESSING SYSTEM?

The FDA product code for VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM 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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