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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 K221738
Device Name NS-HGlio
Applicant
Neosoma Inc.
44 Farmers Row
Groton,  MA  01450
Applicant Contact Aly H Abayazeed
Correspondent
Neosoma Inc.
44 Farmers Row
Groton,  MA  01450
Correspondent Contact Aly H Abayazeed
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/15/2022
Decision Date 09/27/2022
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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