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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K223484
Device Name IGAR System (1001.A)
Applicant
Insight Medbotics Inc.
39 Charlton Avenue East
Hamilton,  CA L8N 1Y3
Applicant Contact Paul Chipperton
Correspondent
Ironstone Product Development
Suite 108, 250 Carlaw Avenue
Toronto,  CA M4M3L1
Correspondent Contact Joel Ironstone
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/18/2022
Decision Date 07/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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