ChiroSight Flat Panel and Software
ChiroSight Flat Panel and Software combines the BIOK7600 digital detector with a PC workstation for diagnostic radiography of adults and children. The detector captures X-rays from a…
ChiroSight Flat Panel and Software combines the BIOK7600 digital detector with a PC workstation for diagnostic radiography of adults and children. The detector captures X-rays from a compatible separate generator and converts them into digital images for processing, display and storage.
The detector automatically senses an exposure and transfers the image through its driver to ChiroSight. The software optimizes the image, stores it in a database and allows manipulation and annotation. Images can also be stored and transferred in DICOM format.
Listed Item
Digital Radiography Flat Panel Detector with ChiroSight Software and PC
Generator Compatibility
The detector requires an independent X-ray generator with a minimum output range of 55 to 120 kVp and at least 30 kW power. Qualified doctors or technologists operate the system. It is not intended for mammography.
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 | Biokinemetrics Inc., United States |
|---|---|
| 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) | K190311 |
| Record published | 2026-04-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2032-04-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIOK7600 | 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 |
|---|---|
| K190311 | 2019-03-13 |
| K190300 | 2019-03-13 |
| K181565 | 2018-07-13 |
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.