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FDA 510(k)

Vitrea Software Package, VSTP-001A

K-Number: K203312 · 2021-02-16

ApplicantCanon Medical Systems Corporation
Decision Date2021-02-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea Software Package, VSTP-001A is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-02-16 under approval number K203312. 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, VSTP-001A?

Vitrea Software Package, VSTP-001A is a medical device that received FDA 510(k) clearance on 2021-02-16. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K203312.

When was Vitrea Software Package, VSTP-001A approved by the FDA?

Vitrea Software Package, VSTP-001A received FDA 510(k) clearance on 2021-02-16, under approval number K203312.

What company makes Vitrea Software Package, VSTP-001A?

Vitrea Software Package, VSTP-001A is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Vitrea Software Package, VSTP-001A?

The FDA product code for Vitrea Software Package, VSTP-001A 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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