Product code MUH
- Device name
- System, X-Ray, Extraoral Source, Digital
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1800
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | 2026-03-03 |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | 2025-11-10 |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | 2025-10-24 |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | 2025-09-24 |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | VATECH Co., Ltd. | 2024-10-25 |
| 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 |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023-10-20 |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 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 |
| K231202 | QuickRayPRO | Denterprise International, Inc. | 2023-06-22 |
| K230811 | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-04-21 |
| K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | 2023-04-11 |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | 2023-02-06 |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022-08-31 |
| K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) | Shanghai Handy Medical Equipment Co., Ltd. | 2022-06-22 |
| K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | 2022-05-19 |
| K220556 | OpenSensorX Series | Dentimax, Inc. | 2022-04-13 |
| K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang , Ltd. | 2022-03-11 |
| K214091 | Dental Image Plate Scanner, Model DFC-4T-SMART | Hefei Dentafilm Medical Equipment Co., Ltd. | 2022-03-02 |
| K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | 2022-02-17 |
| K213637 | JAZZ Solo sensor | Jazz Imaging, LLC Dba Jazz Imaging | 2021-12-10 |
| K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | 2021-10-07 |
| K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-09-27 |
| K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021-09-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860009306110 | Cleartooth Digital X-Ray | CLEARTOOTH ELECTRONICS, INC. | 2026-05-27 |
| 08033837936107 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2026-03-13 |
| 07899581340277 | Intraoral Dental Digital Imaging Sensor | Alliage S/A Indústrias Médico Odontológica | 2023-10-18 |
| 08033837935780 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2022-09-18 |
| 08052870661210 | Acteon | DENTAL XRAY COMPANY SRL | 2019-07-01 |
| 08052870661418 | Acteon | DENTAL XRAY COMPANY SRL | 2019-07-01 |
| 08057737128110 | X-MIND prime | VILLA SISTEMI MEDICALI SPA | 2019-03-08 |
| 08033837931850 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2018-03-30 |
| 08057737127717 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2017-07-24 |
| 08800000500003 | DX3000; iRay; iRay D3 | DEXCOWIN CO., LTD. | 2017-02-28 |
| 08033837931454 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-02-24 |
| 08033837931461 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-02-24 |
| 08033837930334 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-02-10 |
| 08033837930327 | myray | CEFLA SOCIETA' COOPERATIVA | 2017-02-10 |
| 08033837931409 | myray | CEFLA SOCIETA' COOPERATIVA | 2016-10-03 |
| 08033837931416 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2016-10-03 |
| 08057737125416 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127526 | Polaroid - Miri Trading LLC | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127519 | Polaroid - Miri Trading LLC | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127427 | Polaroid - Miri Trading LLC | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127410 | Polaroid - Miri Trading LLC | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127328 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127311 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127229 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737127212 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08057737125218 | Villa Sistemi Medicali | VILLA SISTEMI MEDICALI SPA | 2016-09-24 |
| 08033837930914 | myray | CEFLA SOCIETA' COOPERATIVA | 2016-09-23 |
| 08033837930440 | myray | CEFLA SOCIETA' COOPERATIVA | 2016-09-23 |
| 08033837930716 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2016-09-23 |
| 08033837931317 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2016-09-23 |