Cleared Traditional

K190839 - GammaTile
(FDA 510(k) Clearance)

K190839 · Gt Medical Technologies · Radiology

Jan 2020

Decision

297d

Days

Class 2

Risk

K190839 is an FDA 510(k) clearance for the GammaTile, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Gt Medical Technologies (Tempe, US). The FDA issued a Cleared decision on January 23, 2020, 297 days after receiving the submission on April 1, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K190839 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2019
Decision Date	January 23, 2020
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF