Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1800](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1800) → EHD — Unit, X-Ray, Extraoral With Timer # EHD · Unit, X-Ray, Extraoral With Timer _Dental · 21 CFR 872.1800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD ## Overview - **Product Code:** EHD - **Device Name:** Unit, X-Ray, Extraoral With Timer - **Regulation:** [21 CFR 872.1800](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1800) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 189) Showing 20 most recent of 189 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253864](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K253864.md) | NOMAD Pro 3 | Dental Imaging Technologies Corporation | Mar 20, 2026 | SESE | | [K252110](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K252110.md) | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | Mar 12, 2026 | SESE | | [K254018](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K254018.md) | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | Feb 19, 2026 | SESE | | [K252909](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K252909.md) | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | Feb 3, 2026 | SESE | | [K251438](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K251438.md) | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | Sep 4, 2025 | SESE | | [K242185](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K242185.md) | Rextar Pro | Raypia Co., Ltd. | Dec 4, 2024 | SESE | | [K242591](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K242591.md) | XERO-alpha | DRTECH Corporation | Nov 1, 2024 | SESE | | [K241963](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K241963.md) | WERAY | Picopack Co., Ltd. | Jul 30, 2024 | SESE | | [K241305](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K241305.md) | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | Jul 5, 2024 | SESE | | [K240759](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K240759.md) | REMEX-GR100 | Remedi Co., Ltd. | May 13, 2024 | SESE | | [K233914](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K233914.md) | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | Feb 8, 2024 | SESE | | [K233395](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K233395.md) | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | Jan 3, 2024 | SESE | | [K231055](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K231055.md) | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | Dec 28, 2023 | SESE | | [K232085](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K232085.md) | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | Dec 8, 2023 | SESE | | [K232012](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K232012.md) | N1 | Osstem Implant Co., Ltd. | Nov 28, 2023 | SESE | | [K232068](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K232068.md) | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | Sep 1, 2023 | SESE | | [K231449](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K231449.md) | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | Jul 13, 2023 | SESE | | [K223780](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K223780.md) | Lumos 3DX | 3Dio | Jul 6, 2023 | SESE | | [K221587](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K221587.md) | DHX-70H, XTG-70H | Digimed Co., Ltd. | Mar 3, 2023 | SESE | | [K223010](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD/K223010.md) | Portable X-ray System | Iray Technology Taicang , Ltd. | Jan 17, 2023 | SESE | ## Top Applicants - Planmeca Oy — 13 clearances - Villa Sistemi Medicali S.P.A. — 7 clearances - VATECH Co., Ltd. — 6 clearances - Trophy Radiologie — 6 clearances - Instrumentarium Corp. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com