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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, Tomography, Computed
510(k) Number K170716
Device Name PercuNav Image Fusion and Interventional Navigation
Applicant
Philips Ultrasound, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Peng Cui
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Codes
IYO   LLZ  
Date Received03/09/2017
Decision Date 04/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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