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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K202267
Device Name Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
Applicant
Isoray Medical, Inc.
350 Hills St., Suite 106
Richland,  WA  99354
Applicant Contact Leslie White
Correspondent
Grace Powers - Powers Regulatory Consulting
2451 Cumberland Pkwy. SE
Suite 3740
Atlanta,  GA  30080
Correspondent Contact Grace Powers
Regulation Number892.5730
Classification Product Code
KXK  
Date Received08/11/2020
Decision Date 12/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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