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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 K242359
Device Name Strain AI (SAI001)
Applicant
Exo, Inc.
4201 Burton Dr.
Santa Clara,  CA  95054
Applicant Contact Murray Jacqueline
Correspondent
Exo, Inc.
4201 Burton Dr.
Santa Clara,  CA  95054
Correspondent Contact Jacqueline Murray
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/09/2024
Decision Date 11/20/2024
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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