Vitrea Software Package
K-Number: K192923 · 2020-02-14
ApplicantCanon Medical Systems Corporation
Decision Date2020-02-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vitrea Software Package is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-02-14 under approval number K192923. 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 Vitrea Software Package?
Vitrea Software Package is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K192923.
When was Vitrea Software Package approved by the FDA?
Vitrea Software Package received FDA 510(k) clearance on 2020-02-14, under approval number K192923.
What company makes Vitrea Software Package?
Vitrea Software Package is manufactured by Canon Medical Systems Corporation.
What is the FDA product code for Vitrea Software Package?
The FDA product code for Vitrea Software Package is LLZ.
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Related Devices (Code: LLZ)
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.