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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Visualase ENVISION Workstation
Classification Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Product Code: LNH
Device Class: 2
Regulation Number: 892.1000
Medical Specialty: Radiology
Registered Establishment Name: BIOTEX, INC.
Registered Establishment Number: 3005726841
Owner/Operator: BIOTEX, INC.
Owner/Operator Number: 9079181
Establishment Operations: Manufacturer
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