FDA 510(k)

GammaTile

K-Number: K190839 · 2020-01-23

Decision Date2020-01-23

Product CodeKXK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GammaTile is a medical device manufactured by Gt Medical Technologies. It received FDA 510(k) clearance on 2020-01-23 under approval number K190839. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GammaTile?

GammaTile is a medical device that received FDA 510(k) clearance on 2020-01-23. It is manufactured by Gt Medical Technologies. The 510(k) number is K190839.

When was GammaTile approved by the FDA?

GammaTile received FDA 510(k) clearance on 2020-01-23, under approval number K190839.

What company makes GammaTile?

GammaTile is manufactured by Gt Medical Technologies.

What is the FDA product code for GammaTile?

The FDA product code for GammaTile is KXK.

Other Devices by Gt Medical Technologies

K190296GammaTile K221539GammaTile

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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.