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FDA 510(k)

ARIETTA 50

K-Number: K220295 · 2022-04-29

Decision Date2022-04-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARIETTA 50 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Healthcare Corporation. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220295. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIETTA 50?

ARIETTA 50 is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Fujifilm Healthcare Corporation. The 510(k) number is K220295.

When did ARIETTA 50 receive FDA 510(k) clearance?

ARIETTA 50 received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220295.

Who is the listed applicant for ARIETTA 50?

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

What is the FDA product code for ARIETTA 50?

The FDA product code for ARIETTA 50 is IYN.

Other records listing Fujifilm Healthcare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.