ClearVision ExamVue Flat Panel Detector

GUDID 08809413810013

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 panel b. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detection c. A 17x17in (43x43cm) tethered panel for fixed installations.

JPI HEALTHCARE. CO., LTD.

Indirect flat panel x-ray detector

• Primary Device ID: 08809413810013
• NIH Device Record Key: 51eae8f5-058b-4649-9d14-571447bf49b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearVision ExamVue Flat Panel Detector
• Version Model Number: ClearVision ExamVue Flat Panel Detector
• Company DUNS: 687797852
• Company Name: JPI HEALTHCARE. CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809413810013 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-10-31

Devices Manufactured by JPI HEALTHCARE. CO., LTD.

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