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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 001014 - 2D Quantitative Analysis
Classification Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Product Code: LLZ
Device Class: 2
Regulation Number: 892.2050
Medical Specialty: Radiology
Registered Establishment Name: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Registered Establishment Number: 3003768277
Premarket Submission Number: K161839
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Manufacturer
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