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FDA 510(k)

SMD-Sr90-DA Radionuclide Brachytherapy Source

K-Number: K163206 · 2016-12-15

ApplicantSalutaris Medical Devices, Inc.
Decision Date2016-12-15
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMD-Sr90-DA Radionuclide Brachytherapy Source is a medical device manufactured by Salutaris Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-12-15 under approval number K163206. 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 SMD-Sr90-DA Radionuclide Brachytherapy Source?

SMD-Sr90-DA Radionuclide Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Salutaris Medical Devices, Inc.. The 510(k) number is K163206.

When was SMD-Sr90-DA Radionuclide Brachytherapy Source approved by the FDA?

SMD-Sr90-DA Radionuclide Brachytherapy Source received FDA 510(k) clearance on 2016-12-15, under approval number K163206.

What company makes SMD-Sr90-DA Radionuclide Brachytherapy Source?

SMD-Sr90-DA Radionuclide Brachytherapy Source is manufactured by Salutaris Medical Devices, Inc..

What is the FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source?

The FDA product code for SMD-Sr90-DA Radionuclide Brachytherapy Source is KXK.

Related Clinical Trials

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

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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.

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