FDA 510(k)

DoseCHECK

K-Number: K161946 · 2016-09-16

Decision Date2016-09-16

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DoseCHECK is a medical device manufactured by Sun Nuclear Corporation. It received FDA 510(k) clearance on 2016-09-16 under approval number K161946. 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 DoseCHECK?

DoseCHECK is a medical device that received FDA 510(k) clearance on 2016-09-16. It is manufactured by Sun Nuclear Corporation. The 510(k) number is K161946.

When was DoseCHECK approved by the FDA?

DoseCHECK received FDA 510(k) clearance on 2016-09-16, under approval number K161946.

What company makes DoseCHECK?

DoseCHECK is manufactured by Sun Nuclear Corporation.

What is the FDA product code for DoseCHECK?

The FDA product code for DoseCHECK is IYE.

Other Devices by Sun Nuclear Corporation

K160057ArcCHECK-MR K170307SunCHECK

Related Devices (Code: IYE)

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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.