Unit, X-Ray, Extraoral With Timer
Regulation 872.1800
6510(k)s in 12 months (191 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in EHD
| Company | 510(k)s | Recalls |
|---|---|---|
| Planmeca Oy | 14 | 0 |
| Digimed Co., Ltd. | 6 | 1 |
| Gendex Dental Systems | 1 | 6 |
| Villa Sistemi Medicali S.P.A. | 7 | 0 |
| Trophy Radiologie | 6 | 0 |
| VATECH Co., Ltd. | 6 | 0 |
| Aribex | 3 | 2 |
| Dentsply Intl. | 4 | 0 |
| Gendex Corp. | 3 | 1 |
| Instrumentarium Corp. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2026 | K260795 | Hand-held Dental X-ray System (HyperLight-M) Changzhou Sifary Medical Technology Co., Ltd., CN | EHD |
| May 27, 2026 | K260367 | Portable Dental X-ray System Model PDX nova PDX Co., Ltd., CN | EHD |
| Mar 20, 2026 | K253864 | NOMAD Pro 3 Dental Imaging Technologies Corporation | EHD |
| Mar 12, 2026 | K252110 | Dental X-RAY Unit (AJX200) Guangzhou Ajax Medical Equipment Co., Ltd., CN | EHD |
| Feb 19, 2026 | K254018 | Portable Dental X-ray Device (GT-1) Guilin Refine Medical Instrument Co., Ltd., CN | EHD |
| Feb 3, 2026 | K252909 | Diagnostic X-Ray Equipment Model POCT22 Ningbo Runyes Medical Instrument Co., Ltd., CN | EHD |
| Sep 4, 2025 | K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) Guilin Woodpecker Medical Instrument Co., Ltd., CN | EHD |
| Dec 4, 2024 | K242185 | Rextar Pro Raypia Co., Ltd., KR | EHD |
| Nov 1, 2024 | K242591 | XERO-alpha DRTECH Corporation, KR | EHD |
| Jul 30, 2024 | K241963 | WERAY Picopack Co., Ltd., KR | EHD |
| Jul 5, 2024 | K241305 | LifeRay Intraoral Handheld X-ray System Lucas Lifecare | EHD |
| May 13, 2024 | K240759 | REMEX-GR100 Remedi Co., Ltd., KR | EHD |
| Feb 8, 2024 | K233914 | XVbeam2000 Shenzhen Xpectvision Technology Co., Ltd., CN | EHD |
| Jan 3, 2024 | K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) Alliage S/A Industrias Médico Odontológica, BR | EHD |
| Dec 28, 2023 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) De Götzen S.R.L., IT | EHD |
| Dec 8, 2023 | K232085 | DVAS (DVAS-M, DVAS-W) Genoray Co., Ltd., KR | EHD |
| Nov 28, 2023 | K232012 | N1 Osstem Implant Co., Ltd., KR | EHD |
| Sep 1, 2023 | K232068 | HyperLight Portable X-ray Unit Changzhou Sifary Medical Technology Co., Ltd., CN | EHD |
| Jul 13, 2023 | K231449 | Portable X-ray System Model Ray98(P) Ningbo Runyes Medical Instrument Co., Ltd., CN | EHD |
| Jul 6, 2023 | K223780 | Lumos 3DX 3Dio | EHD |
| Mar 3, 2023 | K221587 | DHX-70H, XTG-70H Digimed Co., Ltd., KR | EHD |
| Jan 17, 2023 | K223010 | Portable X-ray System Iray Technology Taicang , Ltd., CN | EHD |
| Nov 23, 2022 | K222569 | Ai Ray Dental X-Ray Device Guilin Woodpecker Medical Instrument Co., Ltd., CN | EHD |
| Oct 26, 2022 | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) VATECH Co., Ltd., KR | EHD |
| Sep 1, 2022 | K220579 | Hybrid C70 Digimed Co., Ltd., KR | EHD |
| Aug 23, 2022 | K222274 | FONA XDC Fona S.R.L, IT | EHD |
| Jun 29, 2022 | K221286 | CLAROX Vsi Co., Ltd., KR | EHD |
| Jun 27, 2022 | K221233 | DT-703 Ecotron Co., Ltd., KR | EHD |
| Apr 22, 2022 | K220574 | HYBRID S70 Digimed Co., Ltd., KR | EHD |
| Apr 4, 2022 | K213282 | ERI Handheld Dental X-ray System (Model AG100) Energy Resources International Co., Ltd. Hsinchu Branch, TW | EHD |
| Jul 28, 2021 | K211014 | Portray Surround Medical Systems | EHD |
| Dec 28, 2020 | K201800 | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) Nanoray Co., Ltd., KR | EHD |
| Feb 11, 2020 | K200182 | EzRay Air Portable (Model: VEX-P300) VATECH Co., Ltd., KR | EHD |
| Dec 27, 2019 | K192700 | Xcam Hdx Will Corp., KR | EHD |
| Dec 19, 2019 | K190935 | EZER, Portable X-ray System Livermoretech, Inc. | EHD |
| Jun 5, 2019 | K180671 | MINE Rht Co., Ltd., KR | EHD |
| Mar 15, 2019 | K190357 | Star-X, Intraoral X-ray System Hdx Will Corp., KR | EHD |
| Sep 13, 2018 | K182206 | RiX70 DC Trident S.R.L, IT | EHD |
| Aug 10, 2018 | K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) Digimed Co., Ltd., KR | EHD |
| Apr 4, 2018 | K180561 | MobileX Portable X-ray System Denterprise International, Inc. | EHD |
| Mar 16, 2018 | K172928 | Portable X-ray System Rolence Enterprise, Inc., TW | EHD |
| Mar 7, 2018 | K172810 | PORT-X IV Genoray Co., Ltd., KR | EHD |
| Nov 16, 2017 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System Aribex | EHD |
| Jun 8, 2017 | K170967 | Intraskan DC Plus Skanray Technologies Private Limited, IN | EHD |
| Jan 24, 2017 | K163705 | EzRay Air W VATECH Co., Ltd., KR | EHD |
| Jan 13, 2017 | K163519 | RX DC Cefla S.C., IT | EHD |
| Sep 1, 2016 | K161063 | EzRay Air (Model VEX-P300) VATECH Co., Ltd., KR | EHD |
| Jun 20, 2016 | K160458 | BI IMAGE-X EVOLUTION Radiotecnologia Industrial S.A. DE C.V., MX | EHD |
| Dec 3, 2015 | K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012), KR | EHD |
| Sep 3, 2014 | K141293 | PHOT-X IIS MODEL 505 Takara Belmont Corporation | EHD |
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