ExamVue Apex
ExamVue Apex is a digital flat panel X-ray detector system for radiologists and radiology technicians. It supports general and specialist radiography, including orthopedic, podiatric and…
ExamVue Apex is a digital flat panel X-ray detector system for radiologists and radiology technicians. It supports general and specialist radiography, including orthopedic, podiatric and mobile X-ray examinations. It is not intended for mammography.
A cesium iodide scintillator converts X-rays into light, which a silicon thin film detector collects as electronic signals. ExamVue Duo software processes, presents and stores the resulting images in DICOM format.
Listed Item
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.
Detector Options
The system offers EVA 10W, EVA 14W and EVA 17W cassette sized wireless panels. These provide nominal formats of 10 by 12, 14 by 17 and 17 by 17 inches respectively. A wireless or cable interface links the detector to the acquisition system.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (4), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Solid State X-Ray Imager (Flat Panel/Digital Imager)
Record
| Listed by | JPI Healthcare Co., Ltd., South Korea |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K244010 |
| Record published | 2026-05-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EVA 14W | In distribution | |
| EVA 10W | In distribution | |
| EVA 17W | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sedecal | Sedecal., Sa. | 70 |
| Schick33 | Sirona Dental, Inc. | 44 |
| Drgem | Drgem Corporation | 41 |
| Schick | Dentsply LLC | 35 |
| Wireless Digital Flat Panel Detector | iRay Group | 27 |
| Fuji IP Cassette CC | Fujifilm Corporation | 20 |
| Canon Inc. | Canon Inc. | 20 |
| Fona Stellaris | Sirona Dental, Inc. | 20 |
| Exprimer | Drtech Corporation | 18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Samsung Electronics Co., Ltd. | 17 |
| X-ray Flat Panel Detector | Careray Digital Medical Technology Co., Ltd. | 16 |
| Regius Cassette | Konica Minolta, Inc. | 16 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K244010 | 2025-02-24 |
| K160143 | 2016-10-28 |
| K102327 | 2012-04-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.