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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241108
Device Name RemedyLogic AI MRI Lumbar Spine Reader
Applicant
Remedy Logic, Inc.
1177 Ave. Of The Americas, 5th Floor
New York,  NY  10036
Applicant Contact Andrej Rusakov
Correspondent
Bridging Consulting, LLC
2108 N St. Suite N
Sacramento,  CA  95816
Correspondent Contact Yu Zhao
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/22/2024
Decision Date 10/30/2024
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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