Vantage Elan 1.5T, V4.0
K-Number: K171597 · 2017-07-21
ApplicantToshibamedical Systems Corporation
Decision Date2017-07-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Vantage Elan 1.5T, V4.0 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-07-21 under approval number K171597. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vantage Elan 1.5T, V4.0?
Vantage Elan 1.5T, V4.0 is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K171597.
When was Vantage Elan 1.5T, V4.0 approved by the FDA?
Vantage Elan 1.5T, V4.0 received FDA 510(k) clearance on 2017-07-21, under approval number K171597.
What company makes Vantage Elan 1.5T, V4.0?
Vantage Elan 1.5T, V4.0 is manufactured by Toshibamedical Systems Corporation.
What is the FDA product code for Vantage Elan 1.5T, V4.0?
The FDA product code for Vantage Elan 1.5T, V4.0 is LNH.
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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.