Green X 18 (Model: PHT-75CHS)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Green X 18 EUDAMEDFDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Computed Tomography X-ray System EUDAMEDDental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP FDA UDI
- Model / Reference
- PHT-75CHS EUDAMEDFDA UDIVDH-UM-085 EUDAMED
- Description
- Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016400786 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000164PHT75CHS08525 EUDAMED
- 510(k) Number
- K210329 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)FDA UDI
- EMDN Code
- Z11030601 COMPUTED TOMOGRAPHS - NOT EXCEEDING 2 LAYERS EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)FDA UDI
- Market of Registration
- Czechia EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Green X 18 (Model: PHT-75CHS) is a computed dental tomography device designed for high-resolution imaging of dental and maxillofacial structures. It provides three-dimensional volumetric data to support diagnostic and treatment planning in radiology, particularly for dental professionals.
This device is intended for use in clinical settings and is supplied as a reusable medical instrument. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The system requires proper installation, calibration, and maintenance as outlined in the provided manuals, with no specific sterility requirements noted beyond standard medical device hygiene protocols.
Frequently asked questions
What is the primary purpose of the Green X 18 (Model: PHT-75CHS) in clinical settings?
The Green X 18 is designed specifically for high-resolution, three-dimensional imaging of dental and maxillofacial structures. It provides volumetric data to assist dental professionals in diagnostic evaluations and treatment planning, particularly in radiology. The detailed imaging helps visualize complex anatomical features for better clinical decision-making.
Is the Green X 18 a single-use or reusable device, and what hygiene protocols should be followed?
The Green X 18 is supplied as a reusable medical instrument. While no specific sterility requirements are noted beyond standard medical device hygiene protocols, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and safety. Regular calibration and adherence to the provided manuals are also essential.
What regulatory pathways has the Green X 18 followed, and how does this affect its use?
The Green X 18 has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with both U.S. and European regulatory standards. This means it meets the necessary safety and performance requirements for use in clinical settings, though users should always refer to the manufacturer’s instructions and local regulations for proper implementation.
Does the Green X 18 require any special installation or maintenance beyond standard cleaning?
Yes, the Green X 18 requires proper installation, calibration, and maintenance as outlined in the manufacturer’s manuals. These steps are critical to ensure accurate imaging performance and longevity of the device. Skipping or improperly following these procedures could compromise diagnostic reliability.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vatech Green X 18 PHT-75CHS Manuals | ManualsLib, VATECH Green X/X18 Install Manual | AI Chat & PDF | Manualzz, Vatech Green X 18 User Manual | AI Chat & PDF Access | Manualzz, User manual - Vatech America, User Manuals: Vatech Green X PHT-75CHS X-ray Imaging
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210329 | Class II | Active |
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Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (3)
- FDA 510(k) K210329 24 fields · synced Sep 18, 2026
- FDA UDI 789d4c7e-3010-42ab-80f9-77b1566c87c6 34 fields · synced May 30, 2026
- EUDAMED f37ee5f3-9068-4099-9e49-2ae6af080d5b 61 fields · synced Jul 28, 2026