Cleared Special

K111931 - GLIASITE RTS
(FDA 510(k) Clearance)

K111931 · Isoray Medical, Inc. · Radiology

Aug 2011

Decision

28d

Days

Class 2

Risk

K111931 is an FDA 510(k) clearance for the GLIASITE RTS. 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 August 5, 2011, 28 days after receiving the submission on July 8, 2011.

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

Submission Details

510(k) Number	K111931 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2011
Decision Date	August 05, 2011
Days to Decision	28 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF