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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K243842
Device Name Intra-Operative Positioning System (IOPS®)
Applicant
Centerline Biomedical, Inc.
4535 Renaissance Pkwy.
Cleveland,  OH  44128
Applicant Contact Amanda Shade
Correspondent
Centerline Biomedical, Inc.
4535 Renaissance Pkwy.
Cleveland,  OH  44128
Correspondent Contact Amanda Shade
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQX   DQY  
Date Received12/13/2024
Decision Date 03/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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