Sirius MRI Markers, Cs-131 Preloaded Strands With Sirius MRI Markers In 18 Gauge Needles

Source, Brachytherapy, Radionuclide

Isoray Medical, Inc.

The following data is part of a premarket notification filed by Isoray Medical, Inc. with the FDA for Sirius Mri Markers, Cs-131 Preloaded Strands With Sirius Mri Markers In 18 Gauge Needles.

Pre-market Notification Details

Device IDK202267
510k NumberK202267
Device Name:Sirius MRI Markers, Cs-131 Preloaded Strands With Sirius MRI Markers In 18 Gauge Needles
ClassificationSource, Brachytherapy, Radionuclide
Applicant Isoray Medical, Inc. 350 Hills St, Suite 106 Richland,  WA  99354
ContactLeslie White
CorrespondentGrace Powers
Grace Powers - Powers Regulatory Consulting 2451 Cumberland Parkway SE, Suite 3740 Atlanta,  GA  30080
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-11
Decision Date2020-12-31

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