Device
The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a si...
Manufacturer
JPI HEALTHCARE. CO., LTD.
JPI HEALTHCARE. CO., LTD.
Model: EVA 10W
DI: 08809413811096
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system 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. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
68a2ffd5-4d44-404a-a12c-c909b71da935
Distribution Status:
In Commercial Distribution
DUNS Number:
687797852
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08809413811096
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61108
Name: Indirect flat panel x-ray detector
Definition:
An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.
FDA Product Codes
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Premarket Submissions
Submission Number:
K244010
Supplement Number:
000