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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K261788
Device Name Eden PACS
Applicant
Higia., Inc. d/b/a Eden
300 Delaware Ave.
Suite 210 #215
Wilmington,  DE  19801
Applicant Contact Daniel Medina
Correspondent
Hardian Ltd. d/b/a Hardian Health
167-169 Great Portland St.
London,  GB W1W 5PF
Correspondent Contact Michael Pogose
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/29/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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