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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Adaptive Needle Tracker; PercuNav Coaxial Needle Tracker, 13Gx11cm; PercuNav Coaxial Needle Tracker, 13Gx16cm; PercuNav Coaxial Needle Tracker, 16Gx11cm; PercuNav Coaxial Needle Tracker, 17Gx16cm; PercuNav Coaxial Needle Tracker, 18Gx13cm; PercuNav Coaxial Needle Tracker, 18Gx8cm; PercuNav Coaxial Needle Tracker, 20Gx13cm; PercuNav Coaxial Needle Tracker, 20Gx17cm; PercuNav Coaxial Needle Tracker, 20Gx8cm; PercuNav Endocavity Ultrasound Tracker; PercuNav Image Fusion and Interventional Navigation; PercuNav Patient Tracker; PercuNav Ultrasound Tracker
Classification Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Product Code: IYO
Device Class: 2
Regulation Number: 892.1560
Medical Specialty: Radiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K170716
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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