FDA 510(k)

3DVH

K-Number: K131862 · 2013-08-21

Decision Date2013-08-21

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3DVH 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 2013-08-21 under 510(k) number K131862. 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 3DVH?

3DVH is a medical device that received FDA 510(k) clearance on 2013-08-21. The listed applicant is Sun Nuclear Corporation. The 510(k) number is K131862.

When did 3DVH receive FDA 510(k) clearance?

3DVH received FDA 510(k) clearance on 2013-08-21, under 510(k) number K131862.

Who is the listed applicant for 3DVH?

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 3DVH?

The FDA product code for 3DVH 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 K160057ArcCHECK-MR K131466MAPCHECK2, ARCCHECK K131704EPIDOSE

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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.