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FDA 510(k)

SCENARIA View

K-Number: K190841 · 2019-09-13

ApplicantHitachi Healthcare Americas
Decision Date2019-09-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCENARIA View is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K190841. 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 2019-09-13. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K190841.

When did SCENARIA View receive FDA 510(k) clearance?

SCENARIA View received FDA 510(k) clearance on 2019-09-13, under 510(k) number K190841.

Who is the listed applicant for SCENARIA View?

The FDA 510(k) record lists Hitachi Healthcare Americas as the applicant. This does not by itself establish the device manufacturer.

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.

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