SCENARIA View
K-Number: K200498 · 2020-07-17
ApplicantHitachi Healthcare Americas
Decision Date2020-07-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SCENARIA View is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2020-07-17 under approval number K200498. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SCENARIA View?
SCENARIA View is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K200498.
When was SCENARIA View approved by the FDA?
SCENARIA View received FDA 510(k) clearance on 2020-07-17, under approval number K200498.
What company makes SCENARIA View?
SCENARIA View is manufactured by Hitachi Healthcare Americas.
What is the FDA product code for SCENARIA View?
The FDA product code for SCENARIA View is JAK.
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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.