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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 K182907
Device Name SPY Elite Intraoperative Perfusion Assessment System
Applicant
Novadaq Technologies Ulc. (Now A Part of Stryker)
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Applicant Contact Agatha Szeliga
Correspondent
Novadaq Technologies Ulc. (Now A Part of Stryker)
8329 Eastlake Dr. Unit 101
Burnaby,  CA V5A 4W2
Correspondent Contact Agatha Szeliga
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/17/2018
Decision Date 01/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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