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510(k) Data Aggregation
K Number
K052422Device Name
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
Manufacturer
FLOW X-RAY CORP.
Date Cleared
2005-09-27
(25 days)
Product Code
EAP
Regulation Number
872.1810Why did this record match?
Applicant Name (Manufacturer) :
FLOW X-RAY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
Device Description
The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system. The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly Constant-potential radiation system that produces, clear, sharp radiography with minimal elapsed exposure time. Includes 2 versions- integrated and remote, that are compatible to open to open to and the (30 cm round, and equipped with rectangular SSD's available as optional).
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