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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 K240786
Device Name AutoChamber
Applicant
HeartLung Corporation
2450 Holcombe Blvd.
Houston,  TX  77021
Applicant Contact Mark Scott
Correspondent
HeartLung Corporation
2450 Holcombe Blvd.
Houston,  TX  77021
Correspondent Contact Mark Scott
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/22/2024
Decision Date 10/10/2024
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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