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FDA 510(k)

Vitrea Software Package, VSTP-001A

K-Number: K183013 · 2018-11-26

ApplicantCanon Medical Systems Corporation
Decision Date2018-11-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea Software Package, VSTP-001A is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K183013. 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 2018-11-26. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K183013.

When did Vitrea Software Package, VSTP-001A receive FDA 510(k) clearance?

Vitrea Software Package, VSTP-001A received FDA 510(k) clearance on 2018-11-26, under 510(k) number K183013.

Who is the listed applicant for Vitrea Software Package, VSTP-001A?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

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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