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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K230727
Device Name SPY Portable Handheld Imaging (SPY-PHI) System
Applicant
Novadaq Technologies Ulc (A Part of Stryker)
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Applicant Contact Cara Cahill
Correspondent
Novadaq Technologies Ulc (A Part of Stryker)
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Correspondent Contact Cara Cahill
Regulation Number892.1600
Classification Product Code
IZI  
Date Received03/16/2023
Decision Date 06/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT03200704
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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