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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Confocal Optical Imaging
510(k) Number K254180
Device Name PerfusiX-Imaging
Applicant
LIMIS Development B.V.
Henri Dunantweg 2
Leeuwarden,  NL 8934AD
Applicant Contact Kelsey van Abbema
Correspondent
LIMIS Development B.V.
Henri Dunantweg 2
Leeuwarden,  NL 8934AD
Correspondent Contact Kelsey van Abbema
Regulation Number876.1500
Classification Product Code
OWN  
Date Received12/23/2025
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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