FXRD-1012N
The FXRD-1012N wireless detectors capture digital X-ray images for general diagnostic radiography of human anatomy. They are used with an operating computer and a compatible X-ray generator…
The FXRD-1012N wireless detectors capture digital X-ray images for general diagnostic radiography of human anatomy. They are used with an operating computer and a compatible X-ray generator to replace film or screen based image recording. They are not intended for mammography.
A scintillator converts the incoming X-rays into light, which an amorphous silicon array detects and converts into electrical signals. These signals are digitized to create the displayed image. FXRD-1012NAW uses a cesium iodide scintillator, while FXRD-1012NBW uses gadolinium oxysulfide. Both have a 10 by 12 inch imaging area.
Exposure and Communication
The listed NAW and NBW models transmit images wirelessly. Acquisition can be synchronized through a generator trigger connection or use automatic exposure detection. The detector receives the exposure; it does not serve as the control for the X-ray generator.
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) | K152855 |
| Record published | 2016-07-15 |
| 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-1012NAW | Withdrawn | |
| FXRD-1012NBW | 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.