510(k) K213579
- Device
- Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D And Stellaris 3D Ceph
- Applicant
- FONA S.r.l
- 510(k) number
- K213579
- Product code
- MUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-02
- Date received
- 2021-11-10
- Regulation
- 872.1800
- Classification name
- System, X-ray, Extraoral Source, Digital
- Medical specialty
- Dental
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Luigi Germano
- Address
- Via G.Galilei 11 Assago IT 20057 20057
FDA Registration Numbers#
- 3009717300
- 3012957335
- 3005706667
- 3003528079
- 3009543051
- 1226003
- 3004884150
- 8030876
- 2024980
- 3009715136
- 3005843418
- 3015509619
- 3030089802
- 3009196578
- 3031093388
- 3035879459
- 3005383085
- 3005554774
- 3010281549
- 3021551875
- 3002807636
- 3013511605
- 3002819275
- 3030898585
- 3012649815
- 9615832
- 3018999255
- 3008770655
- 3012494290
- 3017403245
- 3014980469
- 3011471624
- 3031886796
- 3004706313
- 3014398772
- 3001052305
- 8043728
- 3010445368
- 3002994636
- 3006610845
- 3016875543
- 8020825
- 9614977
- 3018596740
- 3023322470
- 3007538876
Source Documents#
Other 510(k) Records For Product Code MUH #
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases