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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: TOMTEC-ARENA
Classification Name: AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Product Code: QIH
Device Class: 2
Regulation Number: 892.2050
Medical Specialty: Radiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K201632
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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