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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 K260879
Device Name 4DM
Applicant
INVIA, LLC
3025 Boardwalk Dr., Suite 200
Ann Arbor,  MI  48108
Applicant Contact Edward Ficaro
Correspondent
Emergo by UL
2500 Bee Caves Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Harrison Emery
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received03/17/2026
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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