0909FCB
The FDA filing lists 0909FCB as a digital flat-panel X-ray detector and describes its detector technology. The 0909FCB uses a cesium iodide scintillator to convert X-rays to light and a…
The FDA filing lists 0909FCB as a digital flat-panel X-ray detector and describes its detector technology.
The 0909FCB uses a cesium iodide scintillator to convert X-rays to light and a CMOS active-pixel detector.
Listed Item
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
Image Data
The filing describes low-noise, high-sensitivity detector performance, with no data missing or artifacts from its seamless single-chip CMOS. RAW files can be processed into DICOM-compatible image files by separate console software for radiographic diagnosis and analysis.
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) | K212753 |
| Record published | 2021-10-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 35 °C; Storage environment atmospheric pressure 86 to 106 KiloPascal; Storage environment humidity 10 to 75 % RH; Storage environment temperature -10 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0909FCB | 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.