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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autofluorescence Imaging Adjunct Tool For Wounds
510(k) Number K251678
Device Name Swift Ray 1
Applicant
Swift Medical, Inc.
1 King St. W, Suit 4800-355
Toronto,  CA M5H 1A1
Applicant Contact Tenzin Yangzom
Correspondent
Swift Medical, Inc.
1 King St. W, Suit 4800-355
Toronto,  CA M5H 1A1
Correspondent Contact Tenzin Yangzom
Regulation Number878.4550
Classification Product Code
QJF  
Subsequent Product Code
FXN  
Date Received05/30/2025
Decision Date 02/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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