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FDA 510(k)

SCENARIA View Phase 5.0

K-Number: K250370 · 2025-05-20

ApplicantFujifilm Corporation
Decision Date2025-05-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCENARIA View Phase 5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250370. 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 Phase 5.0?

SCENARIA View Phase 5.0 is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Fujifilm Corporation. The 510(k) number is K250370.

When did SCENARIA View Phase 5.0 receive FDA 510(k) clearance?

SCENARIA View Phase 5.0 received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250370.

Who is the listed applicant for SCENARIA View Phase 5.0?

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

What is the FDA product code for SCENARIA View Phase 5.0?

The FDA product code for SCENARIA View Phase 5.0 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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