GammaTile

FDA 510(k) K180515 · Isoray Medical, Inc.

Substantially Equivalent

510(k) numberK180515

Submission

Device name
GammaTile
Applicant
Isoray Medical, Inc.
Richland, WA, US
Received
February 27, 2018
Decision date
July 6, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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More from C4 Imaging, LLC

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Questions and answers

When was GammaTile cleared by the FDA?

GammaTile (K180515) received a 510(k) decision of Substantially Equivalent on July 6, 2018, 129 days after the submission was received.

What is the product code of K180515?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.