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FDA 510(k)

Scenaria View 4.2

K-Number: K231574 · 2023-10-12

Decision Date2023-10-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Scenaria View 4.2 is a medical device manufactured by FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-10-12 under approval 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. It is manufactured by FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231574.

When was Scenaria View 4.2 approved by the FDA?

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

What company makes Scenaria View 4.2?

Scenaria View 4.2 is manufactured by FUJIFILM Healthcare Americas Corporation.

What is the FDA product code for Scenaria View 4.2?

The FDA product code for Scenaria View 4.2 is JAK.

Other Devices by FUJIFILM Healthcare Americas Corporation

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Related Devices (Code: JAK)

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.