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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Affiniti Circular Edition Diagnostic Ultrasound System; Affiniti Diagnostic Ultrasound Systems; CX50 Circular Edition Diagnostic Ultrasound System; Cx50 Diagnostic Ultrasound System; CX50 Diamond Select Diagnostic Ultrasound System; EPIQ Circular Edition Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound Systems; Lumify Circular Edition Diagnostic Ultrasound System; Lumify Diagnostic Ultrasound System; Lumify Diamond Select Diagnostic Ultrasound System; QLAB Advanced Quantification Software; Sparq Circular Edition Diagnostic Ultrasound System; Sparq Diagnostic Ultrasound System; Sparq Diamond Select Diagnostic Ultrasound System
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: K201012
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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