Green X 21 (PHT-90CHO)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Green X EUDAMEDFDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Computed Tomography X-ray System EUDAMEDGreen X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X (Model: PHT-75CHS)is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector. FDA UDI
- Model / Reference
- PHT-75CHS EUDAMEDFDA UDIVDH-UM-085 EUDAMED
- Description
- Green X (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X (Model: PHT-75CHS)is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016400700 EUDAMEDFDA UDI08800016400717 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000164PHT75CHS08525 EUDAMED
- 510(k) Number
- K243081 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 EUDAMEDFrance 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 21 (PHT-90CHO) is a computed dental tomography device designed for high-resolution imaging of dental and maxillofacial structures. Classified as a Class II medical device under FDA regulations, it provides detailed cross-sectional views to support diagnostic and treatment planning in radiology.
This device is supplied as a reusable system intended for use in clinical radiology settings. It operates under FDA 510(k) clearance and EU MDR compliance, with no specific sterility requirements stated. The system is not labeled as MRI-safe or unsafe, and its operation depends on the specific model variant and software version. Authorisations include traditional 510(k) clearance with a decision date of February 14, 2025.
Frequently asked questions
What is the primary purpose of the Green X 21 (PHT-90CHO) in a clinical setting?
The Green X 21 (PHT-90CHO) is a computed dental tomography device designed specifically for high-resolution imaging of dental and maxillofacial structures. It provides detailed cross-sectional views, which are essential for diagnostic evaluations and treatment planning in radiology, particularly for oral and maxillofacial assessments.
Is the Green X 21 (PHT-90CHO) intended for single-use or reusable applications?
The Green X 21 (PHT-90CHO) is supplied as a reusable system, intended for use in clinical radiology settings. Since it is not labeled with specific sterility requirements, proper cleaning and maintenance protocols must be followed to ensure safe reuse across multiple patients.
What regulatory pathways has the Green X 21 (PHT-90CHO) undergone, and what does this mean for its use?
The device has obtained both FDA 510(k) clearance and EU MDR compliance, confirming its classification as a Class II medical device under FDA regulations. The 510(k) clearance, granted on February 14, 2025, indicates that it is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and effectiveness standards for dental and maxillofacial imaging.
Does the Green X 21 (PHT-90CHO) have any specific compatibility considerations, such as MRI safety?
The device is not explicitly labeled as MRI-safe or MRI-unsafe. Compatibility with MRI environments would depend on the specific model variant and software version in use, so clinicians should verify compatibility with their facility’s MRI protocols before integrating the device into an MRI setting.
How is the Green X 21 (PHT-90CHO) categorized in terms of its intended use within the regulatory system?
The device falls under the product code OAS and is classified within the Radiology medical specialty. It is also associated with the Radiology (RA) advisory committee, which reviews submissions related to imaging technologies, ensuring its intended use aligns with diagnostic and treatment planning needs in dental and maxillofacial radiology.
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.
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 | K243081 | Class II | Active |
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Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (5)
- FDA 510(k) K243081 24 fields · synced Sep 18, 2026
- FDA UDI 33c1460b-ad78-45f4-aec2-d5210f533b9f 34 fields · synced May 29, 2026
- FDA UDI e631d012-4130-4eb1-8995-1ed19847ef4d 34 fields · synced May 30, 2026
- EUDAMED cd8a5015-54e5-4480-abc2-a6899fdf0380 61 fields · synced Jul 22, 2026
- EUDAMED 3f30a451-dc0e-4f7a-80b5-34efad852f32 61 fields · synced Jul 28, 2026