1717WCE-HR
The 1717WCE-HR is a digital flat-panel X-ray detector for general diagnostic radiography. It is used with an external X-ray generator and operating software to capture and digitise…
The 1717WCE-HR is a digital flat-panel X-ray detector for general diagnostic radiography. It is used with an external X-ray generator and operating software to capture and digitise exposures, and is not intended for mammography.
A scintillator converts the incoming X-rays into light coupled to a thin-film-transistor sensor. The detector can send captured image data through wired or wireless communication, with separate console software processing raw files into DICOM-compatible images.
Listed Item
Solid state x-ray imager(flat panel/digital imager)
HR Configuration
The HR model is the white detector with a 99.9-micrometre pixel pitch. This differs from the basic 1717WCE model’s larger pixel pitch while retaining the same fundamental detector design.
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 | Rayence 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 | Manufacturer |
| 510(k) | K242394 |
| Record published | 2024-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1717WCE-HR | 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 |
|---|---|
| K253800 | 2026-07-31 |
| K242394 | 2024-09-09 |
| K240371 | 2024-03-07 |
| K231467 | 2023-06-21 |
| K212753 | 2021-10-18 |
| K210985 | 2021-04-28 |
| K202722 | 2020-10-26 |
| K201796 | 2020-07-23 |
| K171418 | 2017-06-12 |
| K171417 | 2017-06-12 |
| K171420 | 2017-06-09 |
| K171419 | 2017-06-09 |
| K162519 | 2016-10-06 |
| K162518 | 2016-10-06 |
| K150150 | 2015-03-27 |
| K141566 | 2014-07-16 |
| K141563 | 2014-07-16 |
| K140056 | 2014-05-13 |
| K140060 | 2014-05-13 |
| K140646 | 2014-04-11 |
| K133409 | 2014-02-21 |
| K131114 | 2013-09-17 |
| K130935 | 2013-07-02 |
| K123345 | 2013-03-12 |
| K122928 | 2013-01-30 |
| K122919 | 2013-01-01 |
| K122173 | 2012-10-19 |
| K122182 | 2012-08-16 |
| K113630 | 2011-12-29 |
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.