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FDA 510(k)

ARIETTA 50

K-Number: K190248 · 2019-04-02

Decision Date2019-04-02
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 Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-04-02 under 510(k) number K190248. 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 2019-04-02. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K190248.

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

ARIETTA 50 received FDA 510(k) clearance on 2019-04-02, under 510(k) number K190248.

Who is the listed applicant for ARIETTA 50?

The FDA 510(k) record lists Hitachi Healthcare Americas 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 Hitachi Healthcare Americas 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.

View all 17 devices →

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

View on FDA Database →

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