GammaTile
K-Number: K180515 · 2018-07-06
ApplicantIsoray Medical, Inc.
Decision Date2018-07-06
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
GammaTile is a medical device manufactured by Isoray Medical, Inc.. It received FDA 510(k) clearance on 2018-07-06 under approval number K180515. 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 2018-07-06. It is manufactured by Isoray Medical, Inc.. The 510(k) number is K180515.
When was GammaTile approved by the FDA?
GammaTile received FDA 510(k) clearance on 2018-07-06, under approval number K180515.
What company makes GammaTile?
GammaTile is manufactured by Isoray Medical, Inc..
What is the FDA product code for GammaTile?
The FDA product code for GammaTile is KXK.
Other Devices by Isoray Medical, Inc.
Related Devices (Code: KXK)
K163206SMD-Sr90-DA Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc.
K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSource Production and Equipment Co., Inc.
K161396SPEC Model M23Source Production and Equipment Co., Inc.
K161395SPEC Model M13Source Production and Equipment Co., Inc.
K171487Sirius MRI Marker NSC4 Imaging, LLC
K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp.
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.