GammaTile

FDA 510(k) K190296 · Gt Medical Technologies

Substantially Equivalent

510(k) numberK190296

Submission

Device name
GammaTile
Applicant
Gt Medical Technologies
Tempe, AZ, US
Received
February 11, 2019
Decision date
March 13, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 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 (K190296) received a 510(k) decision of Substantially Equivalent on March 13, 2019, 30 days after the submission was received.

What is the product code of K190296?

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