FDA 510(k)

ArcCHECK-MR

K-Number: K160057 · 2016-05-13

Decision Date2016-05-13

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ArcCHECK-MR is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corporation. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K160057. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArcCHECK-MR?

ArcCHECK-MR is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Sun Nuclear Corporation. The 510(k) number is K160057.

When did ArcCHECK-MR receive FDA 510(k) clearance?

ArcCHECK-MR received FDA 510(k) clearance on 2016-05-13, under 510(k) number K160057.

Who is the listed applicant for ArcCHECK-MR?

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

What is the FDA product code for ArcCHECK-MR?

The FDA product code for ArcCHECK-MR is IYE.

Other records listing Sun Nuclear 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.

K170307SunCHECK K161946DoseCHECK

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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.