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510(k) Data Aggregation
K Number
K121132Device Name
EZSENSOR P DIGITAL INTRAORAL SENSOR
Manufacturer
HUMANRAY CO,LTD
Date Cleared
2012-05-10
(27 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
HUMANRAY CO,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EzSensor P, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Device Description
The EzSensor P digital intra oral sensor is a solid state x-ray imager designed for dental radiographic applications. The EzSensor P digital intra oral sensor provides digital diagnostic image capture to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to personal computer via USB interface port.
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K Number
K113360Device Name
MEDICAL IMAGE PROCESSING UNIT
Manufacturer
HUMANRAY CO,LTD
Date Cleared
2012-02-07
(85 days)
Product Code
EAP
Regulation Number
872.1810Why did this record match?
Applicant Name (Manufacturer) :
HUMANRAY CO,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EzSensor T, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Device Description
EzSensor T is a solid state x-ray imager designed for dental radiographic applications. EzSensor T provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.
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