FDA 510(k)

ARIETTA PRECISION

K-Number: K163505 · 2017-05-30

Decision Date2017-05-30

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ARIETTA PRECISION is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K163505. 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 PRECISION?

ARIETTA PRECISION is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Hitachi , Ltd.. The 510(k) number is K163505.

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

ARIETTA PRECISION received FDA 510(k) clearance on 2017-05-30, under 510(k) number K163505.

Who is the listed applicant for ARIETTA PRECISION?

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

What is the FDA product code for ARIETTA PRECISION?

The FDA product code for ARIETTA PRECISION is IYN.

Other records listing Hitachi , Ltd. 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.

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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.