Green X 12 SE (PHT-40CHS)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Green X 12 EUDAMEDFDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Computed Tomography X-ray System EUDAMEDPHT-75CHS(SP12X8.5)(US)/P(W-PAN P)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 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
- PHT-75CHS(SP12X8.5)(US)/P(W-PAN P)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 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
- 08800016401837 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000164PHT75CHS08525 EUDAMED
- 510(k) Number
- K243088 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 12 SE (PHT-40CHS) is a Computed Dental Tomography Device (per OpenFDA classification) designed for dental radiography. It integrates panoramic, cephalometric, 3D Cone Beam Computed Tomography (CBCT), and model scanning modalities into a single system, enabling comprehensive dental and maxillofacial imaging.
This device is intended for use in radiology settings and is supplied as a reusable Class II medical device. It operates under FDA 510(k) clearance (K243088) and MDR compliance, with no third-party reprocessing flag. The PHT-40CHS model is specified for dental imaging applications, adhering to regulation 892.1750. Storage and handling follow standard medical imaging protocols.
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 12 Se (PHT-40CHS) - allmed.wiki, Green X 12 - Vatech America, Green X 12 SE (PHT-40CHS) | FDA Radiology AI Device
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 | K243088 | Class II | Active |
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Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (3)
- FDA 510(k) K243088 24 fields · synced Sep 18, 2026
- FDA UDI 79036e46-4354-4cb7-a6d7-18777c3d7aa5 34 fields · synced May 30, 2026
- EUDAMED 341b6241-549c-4a81-87c0-975dae835d76 61 fields · synced Jul 18, 2026