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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 K233822
Device Name i2Contour
Applicant
MRIMath LLC
3473 Birchwood Lane
Birmingham,  AL  35243
Applicant Contact Hassan Fathallah-Shaykh
Correspondent
ProMedic Consulting LLC
131 Bay Point Dr NE
Saint Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/01/2023
Decision Date 08/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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