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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Achieva R4 1.5T (Ingenia); Achieva R4 3.0T (ingenia); dS MICROSCOPY 23MM COIL, INGENIA 1.5T; dS MICROSCOPY 23MM COIL, INGENIA 3.0T; dS MICROSCOPY 47MM COIL, INGENIA 1.5T; dS MICROSCOPY 47MM COIL, INGENIA 3.0T; Ingenia 1.5T; Ingenia 3.0T; Ingenia CX 1.5T; Ingenia CX 3.0T; MICROSCOPY COIL SET, INGENIA 1.5T; MICROSCOPY COIL SET, INGENIA 3.0T; wBTS Sensor Set, ECG 1.0 meter - 98980319364X; wBTS wPPU Sensor Accessories - 98980319363X; wBTU PPU + RESP Module - 98980319445X; wBTU VCG Module - 98980319444X
Classification Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Product Code: LNH
Device Class: 2
Regulation Number: 892.1000
Medical Specialty: Radiology
Registered Establishment Name: Philips Electronics Ltd
Registered Establishment Number: 3000126629
Premarket Submission Number: K110151
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Foreign Exporter
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