Cleared Traditional

K180515 - GammaTile
(FDA 510(k) Clearance)

K180515 · Isoray Medical, Inc. · Radiology

Jul 2018

Decision

129d

Days

Class 2

Risk

K180515 is an FDA 510(k) clearance for the GammaTile. This device is classified as a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK).

Submitted by Isoray Medical, Inc. (Richland, US). The FDA issued a Cleared decision on July 6, 2018, 129 days after receiving the submission on February 27, 2018.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K180515 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2018
Decision Date	July 06, 2018
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF