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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Capsule Endoscopy Analysis Software Device
510(k) Number K254230
Device Name CapsoView (CVV); CapsoCloud (CLD)
Applicant
CapsoVision, Inc.
18805 Cox Ave.
Suite 250
Saratoga,  CA  95070
Applicant Contact Azimun Jamal
Correspondent
CapsoVision, Inc.
18805 Cox Ave.
Suite 250
Saratoga,  CA  95070
Correspondent Contact Zane Liu
Classification Product Code
QZF  
Date Received12/29/2025
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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