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FDA 510(k)

SCENARIA View Phase 5.0

K-Number: K250370 · 2025-05-20

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

Device Summary

SCENARIA View Phase 5.0 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-20 under approval 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. It is manufactured by Fujifilm Corporation. The 510(k) number is K250370.

When was SCENARIA View Phase 5.0 approved by the FDA?

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

What company makes SCENARIA View Phase 5.0?

SCENARIA View Phase 5.0 is manufactured by Fujifilm Corporation.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.