Vitrea Software Package, VSTP-001A
K-Number: K182601 · 2018-12-14
ApplicantCanon Medical Systems Corporation
Decision Date2018-12-14
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 2018-12-14 under approval number K182601. 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 2018-12-14. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K182601.
When was Vitrea Software Package, VSTP-001A approved by the FDA?
Vitrea Software Package, VSTP-001A received FDA 510(k) clearance on 2018-12-14, under approval number K182601.
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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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.