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FDA 510(k)

ArcCHECK-MR

K-Number: K160057 · 2016-05-13

ApplicantSun Nuclear Corporation
Decision Date2016-05-13
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ArcCHECK-MR is a medical device manufactured by Sun Nuclear Corporation. It received FDA 510(k) clearance on 2016-05-13 under approval 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. It is manufactured by Sun Nuclear Corporation. The 510(k) number is K160057.

When was ArcCHECK-MR approved by the FDA?

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

What company makes ArcCHECK-MR?

ArcCHECK-MR is manufactured by Sun Nuclear Corporation.

What is the FDA product code for ArcCHECK-MR?

The FDA product code for ArcCHECK-MR is IYE.

Other Devices by Sun Nuclear Corporation

K161946DoseCHECK K170307SunCHECK

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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.

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