510(k) K160788
- Device
- RIOScan (RPS500)
- Applicant
- RAY CO., Ltd
- 510(k) number
- K160788
- Product code
- MUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-04-15
- Date received
- 2016-03-22
- Regulation
- 872.1800
- Classification name
- System, X-ray, Extraoral Source, Digital
- Medical specialty
- Dental
- Review panel
- Radiology
- Clearance type
- Traditional
- Third party reviewed
- No
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|---|---|---|---|
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| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | 2025-10-24 |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | 2025-09-24 |
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| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | 2024-10-11 |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | 2024-07-05 |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024-04-18 |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023-12-20 |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | 2023-11-21 |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-10-20 |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023-10-20 |
| K230916 | WeSensor | Picopack, Inc. | 2023-10-10 |
| K232255 | EZSensor XHD | Qpix Solutions, Inc. | 2023-09-27 |
| K232158 | GenX-CR | Genoray Co., Ltd. | 2023-09-13 |
Legacy Summary#
summary
FDA Review#
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