FDA 510(k)

DoseCHECK

K-Number: K161946 · 2016-09-16

Decision Date2016-09-16

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DoseCHECK 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 2016-09-16 under 510(k) 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. The listed applicant is Sun Nuclear Corporation. The 510(k) number is K161946.

When did DoseCHECK receive FDA 510(k) clearance?

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

Who is the listed applicant for DoseCHECK?

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 DoseCHECK?

The FDA product code for DoseCHECK 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 K160057ArcCHECK-MR

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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.