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) → MUH — System, X-Ray, Extraoral Source, Digital # MUH · System, X-Ray, Extraoral Source, Digital _Dental · 21 CFR 872.1800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH ## Overview - **Product Code:** MUH - **Device Name:** System, X-Ray, Extraoral Source, Digital - **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 206) Showing 20 most recent of 206 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251793](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K251793.md) | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | Mar 3, 2026 | SESE | | [K252570](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K252570.md) | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | Nov 10, 2025 | SESE | | [K250687](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K250687.md) | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | Oct 24, 2025 | SESE | | [K251206](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K251206.md) | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | Sep 24, 2025 | SESE | | [K240040](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K240040.md) | 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. | Oct 25, 2024 | SESE | | [K242778](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K242778.md) | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | Oct 11, 2024 | SESE | | [K241649](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K241649.md) | DUO1 and DUO2 | Zinnovi, Inc. | Jul 5, 2024 | SESE | | [K232325](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K232325.md) | RAYSCAN a-Expert | Ray Co., Ltd. | Apr 18, 2024 | SESE | | [K231660](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K231660.md) | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | Dec 20, 2023 | SESE | | [K233053](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K233053.md) | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | Nov 21, 2023 | SESE | | [K232552](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K232552.md) | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | Oct 20, 2023 | SESE | | [K230998](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K230998.md) | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | Oct 20, 2023 | SESE | | [K230916](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K230916.md) | WeSensor | Picopack, Inc. | Oct 10, 2023 | SESE | | [K232255](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K232255.md) | EZSensor XHD | Qpix Solutions, Inc. | Sep 27, 2023 | SESE | | [K232158](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K232158.md) | GenX-CR | Genoray Co., Ltd. | Sep 13, 2023 | SESE | | [K231202](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K231202.md) | QuickRayPRO | Denterprise International, Inc. | Jun 22, 2023 | SESE | | [K230811](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K230811.md) | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | Apr 21, 2023 | SESE | | [K230732](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K230732.md) | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | Apr 11, 2023 | SESE | | [K230095](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K230095.md) | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | Feb 6, 2023 | SESE | | [K221955](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH/K221955.md) | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | Aug 31, 2022 | SESE | ## Top Applicants - VATECH Co., Ltd. — 8 clearances - Sirona Dental Systems GmbH — 7 clearances - Genoray Co., Ltd. — 7 clearances - Trophy — 6 clearances - Soredex Palodex Group OY — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/MUH) **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