Expd 86p, Expd 86PG, Expd 129p, Expd 129PG
The EXPD 86P, 86PG, 129P and 129PG are digital X-ray detectors for general diagnostic radiography. They replace film or screen image capture in a compatible radiographic system. They are…
The EXPD 86P, 86PG, 129P and 129PG are digital X-ray detectors for general diagnostic radiography. They replace film or screen image capture in a compatible radiographic system. They are intended for adult and pediatric imaging and are not intended for mammography.
The detectors convert incoming X-rays into visible light. An optical sensor collects that light and produces electrical charge corresponding to the X-ray image. Thin film transistors read the charge, and the signal is amplified and converted into digital image data for viewing, transmission or storage.
Listed Item
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. It is intended for both adult and pediatric populations.
Panel Configurations
The 86P and 86PG have a 17 by 34 inch detector format, while the 129P and 129PG use a 17 by 51 inch format. The detector sends images to the console computer; generator energy is controlled by the radiography software.
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 | Drtech Corporation, 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 | Contract manufacturer, Manufacturer |
| 510(k) | K223124 |
| Record published | 2022-11-29 |
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 |
|---|---|---|
| EXPD 129PG | In distribution | |
| EXPD 129P | In distribution | |
| EXPD 86PG | In distribution | |
| EXPD 86P | 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 |
|---|---|
| K242770 | 2025-03-20 |
| K243443 | 2025-03-19 |
| K232082 | 2024-02-13 |
| K232753 | 2023-11-16 |
| K231959 | 2023-08-01 |
| K223124 | 2022-11-18 |
| K193031 | 2019-11-22 |
| K193017 | 2019-11-22 |
| K192400 | 2019-10-03 |
| K171137 | 2017-05-15 |
| K162555 | 2016-12-21 |
| K162552 | 2016-12-02 |
| K151942 | 2015-10-21 |
| K142475 | 2015-01-15 |
| K132842 | 2014-02-21 |
| K111583 | 2011-10-04 |
| K102474 | 2011-03-04 |
| K080064 | 2008-01-23 |
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.