Cleared Traditional

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

K202267 · Isoray Medical, Inc. · Radiology

Dec 2020

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K202267 is an FDA 510(k) clearance for the Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles, 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 December 31, 2020, 142 days after receiving the submission on August 11, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K202267 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2020
Decision Date	December 31, 2020
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF