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510(k) Data Aggregation
K Number
K142930Device Name
Exam Vue DR
Manufacturer
JPI HEALTHCARE CO., LTD
Date Cleared
2015-04-17
(190 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
JPI HEALTHCARE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Exam Vue DR is a software for the acquisition, processing, storage and viewing of two-dimensional digital radiology images. Exam Vue DR is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.
ExamVue DR is not indicated for use in mammography.
Device Description
The Exam Vue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3tt party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
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K Number
K102327Device Name
CLEARVISION DR 7000F
Manufacturer
JPI HEALTHCARE CO., LTD
Date Cleared
2012-04-13
(605 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
JPI HEALTHCARE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clear Vision DR7000F product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,. chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The Clear Vision DR7000F system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.
Device Description
The Clear Vision DR7000F system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.
The detector which is used proposed device is LTX240AA01-A (K090742) and LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd. These detectors are cleared by FDA 510(k).
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K Number
K101779Device Name
CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
Manufacturer
JPI HEALTHCARE CO., LTD
Date Cleared
2011-05-16
(325 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
JPI HEALTHCARE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clear Vision DR 2000 product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.
Device Description
The Clear Vision DR2000 system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.
The detector which is used proposed device is QXR9 (K073056) and QXR16 (K080553) of Vieworks Co., Ltd. These detectors are cleared by FDA 510(k).
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K Number
K955706Device Name
JPI AUTOMATIC X-RAY FILM PROCESSOR
Manufacturer
JPI HEALTHCARE CO., LTD
Date Cleared
1996-02-12
(59 days)
Product Code
IXW
Regulation Number
892.1900Why did this record match?
Applicant Name (Manufacturer) :
JPI HEALTHCARE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954161Device Name
JPI INTENSIFYING SCREEN
Manufacturer
JPI HEALTHCARE CO., LTD
Date Cleared
1996-02-02
(150 days)
Product Code
EAM
Regulation Number
892.1960Why did this record match?
Applicant Name (Manufacturer) :
JPI HEALTHCARE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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