JPI HEALTHCARE. CO., LTD.

Address:28, Digital-ro 33-gil,Seoul,KR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Cassette, Radiographic Film (IXA) (4) Grid, Radiographic (IXJ) (2) Processor, Radiographic-Film, Automatic (IXW) (1) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1) System, Image Processing, Radiological (LLZ) (1) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

Clear

ClearVision ExamVue Flat Panel Detector - 08809413810013 Catalog Number :

Device Description : The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different mo The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:a. A 14x17in (35x43cm) tethered cassette sized panelb. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detectionc. A 17x17in (43x43cm) tethered panel for fixed installations.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

ExamVue - 08809413810143 Catalog Number :

Device Description : The ExamVue DR software is designed for use by radiologists and radiology techni The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR 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.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

ExamVue - 08809413810174 Catalog Number :

Device Description : The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Automatic Radiographic Film Processor - 08809413810181 Catalog Number :

Device Description : New retractable feed tray provides space savings for small dark rooms.Exceptiona New retractable feed tray provides space savings for small dark rooms.Exceptionally quiet operation.1. Microprocessor controlled.2. High-quality film image3. The control panel digitally displays.4. Water level sensor prevents overflowing of tank.5. Stand-by mode for energy saving.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXW

Prescription Use : No

Device Count : 1

Radiographic Film Cassette - 08809413810198 Catalog Number :

Device Description : Improving Image Quality Reducing Patient Exposure, Being Easy-to-handle.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Radiographic grid - 08809413810204 Catalog Number :

Device Description : A component of an x-ray system used in diagnostic x-ray imaging applications, e. A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.

Device Class : 1

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXJ

Prescription Use : No

Device Count : 1

Radiographic Grid - 08809413810211 Catalog Number :

Device Description : A component of an x-ray system used in diagnostic x-ray imaging applications, e. A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.

Device Class : 1

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXJ

Prescription Use : No

Device Count : 1

Radiographic Film Cassette - 08809413810228 Catalog Number :

Device Description : Improving Image Quality Reducing Patient Exposure, Being Easy-to-handle.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Radiographic Film Cassette - 08809413810235 Catalog Number :

Device Description : Improving Image Quality Reducing Patient Exposure, Being Easy-to-handle.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

Radiographic Film Cassette - 08809413810242 Catalog Number :

Device Description : Improving Image Quality Reducing Patient Exposure, Being Easy-to-handle.

Device Class : 2

Duns Number: 687797852

Premarket Exempt : No

Product Code : IXA

Prescription Use : No

Device Count : 1

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