PHT-75CHS(RC12X8.5)(US)/P(W-PAN P)+C(W-CEPH)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images…
PHT-75CHS(RC12X8.5)(US)/P(W-PAN P)+C(W-CEPH)+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.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
Record
Regulatory record for Green X 12 | Listed by | Vatech Co., Ltd., South Korea |
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Manufacturer |
| Record published | 2023-08-21 |
| Record revised | 2024-02-19 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Storage environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 86 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 86 to 106 KiloPascal |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.