Xaminer Detector Head
Catalogue number X3C, listed by Imaging Dynamics Company, Ltd., Canada, under Solid State X-Ray Imager (Flat Panel/Digital Imager). 13 manufacturers in China are registered for this product code.
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 | Imaging Dynamics Company, Ltd., Canada |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Record published | 2017-01-26 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 40 °C; Handling environment temperature 15 to 30 °C |
| Sizes | Weight 47.75 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X3C | Weight 47.75 kg | 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 |
|---|---|
| K173273 | 2017-11-09 |
| K171169 | 2017-10-12 |
| K171175 | 2017-10-05 |
| K170202 | 2017-02-22 |
| K111098 | 2011-05-27 |
| K070079 | 2007-01-31 |
| K063039 | 2006-11-02 |
| K062586 | 2006-09-29 |
| K042041 | 2004-09-17 |
| K992955 | 2000-06-02 |
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.