Cleared Traditional

GammaTile

K221539 · Gt Medical Technologies · Radiology

Nov 2022

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K221539 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 November 9, 2022, 166 days after receiving the submission on May 27, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K221539 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2022
Decision Date	November 09, 2022
Days to Decision	166 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF