ViVIX-S Wiht VXvue
ViVIX-S with VXvue converts X ray exposures into digital images for general radiography. It replaces film or screen based image capture when integrated with an X ray generator and an…
ViVIX-S with VXvue converts X ray exposures into digital images for general radiography. It replaces film or screen based image capture when integrated with an X ray generator and an operating computer. The listed flat panel detector provides the image receiving part of that arrangement.
A scintillator converts incoming X ray photons to visible light. An array of amorphous silicon photodetectors then converts that light to electrical signals, which are digitized and displayed on a monitor. The detector works with software for image processing and information handling.
Examination Limits
The system is intended for general diagnostic radiography of human anatomy. It is not intended for mammography or fluoroscopy. Its use therefore concerns individual radiographic images rather than continuous fluoroscopic imaging.
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 | Vieworks 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 | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122866 |
| Record published | 2016-07-08 |
| Record revised | 2020-01-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FXRD-1717SB | Withdrawn |
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 |
|---|---|
| K260820 | 2026-06-18 |
| K241125 | 2024-11-15 |
| K220239 | 2022-09-13 |
| K221512 | 2022-07-20 |
| K200418 | 2020-03-18 |
| K190611 | 2019-04-08 |
| K181003 | 2018-05-15 |
| K163703 | 2017-02-08 |
| K152894 | 2016-02-26 |
| K152855 | 2016-02-26 |
| K122865 | 2013-02-01 |
| K122866 | 2013-01-11 |
| K120020 | 2012-05-04 |
| K073056 | 2007-11-13 |
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.