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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D9-3v; Affiniti 30 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System; BP10-5ec; C10-3v; C10-4ec; C5-1; C6-2; C8-5; C9-2; C9-4v; D2cwc; D2tcd; D5cwc; EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; L12-3; L12-4; L12-5 50; L15-7io; L18-5; S12-4; S4-2; S5-1; S7-3t; S8-3; V6-2; VL13-5; X5-1; X6-1; X7-2; X7-2t
Classification Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Product Code: IYN
Device Class: 2
Regulation Number: 892.1550
Medical Specialty: Radiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K160807
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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