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FDA 510(k)

Scenaria View 4.2

K-Number: K231574 · 2023-10-12

ApplicantFUJIFILM Healthcare Americas Corporation
Decision Date2023-10-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Scenaria View 4.2 is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K231574. 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 4.2?

Scenaria View 4.2 is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231574.

When did Scenaria View 4.2 receive FDA 510(k) clearance?

Scenaria View 4.2 received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231574.

Who is the listed applicant for Scenaria View 4.2?

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

What is the FDA product code for Scenaria View 4.2?

The FDA product code for Scenaria View 4.2 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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