Green X 21
Green X 21 is a dental imaging system that produces panoramic and three-dimensional X-ray images, with cephalometric imaging available in the corresponding configuration. It supports…
Green X 21 is a dental imaging system that produces panoramic and three-dimensional X-ray images, with cephalometric imaging available in the corresponding configuration. It supports assessment of the teeth, jaws, sinuses, temporomandibular joints and ENT anatomy.
The system combines digital detectors, an X-ray generator and image viewing software. Its platform also includes model imaging and face scanning, alongside dental and ENT CT modes.
Listed Item
PHT-90CHO(OS21X19)/P(JUPI1012X)+C(VENU1012VD)+CT+TUBE/MASTER
Users and Configuration
Model PHT-90CHO is intended for adult and pediatric patients and is operated by healthcare professionals. The cephalometric option uses one-shot image capture, while CT and panoramic imaging use their associated detector and reconstruction workflow.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Yian Medical Technology (Haining) Co., Ltd. | Jiaxing | Zhejiang | Specification developer | 1 |
| Changzhou Finno Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
Record
| 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 |
| 510(k) | K243081 |
| Record published | 2025-11-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 35 °C; Storage environment atmospheric pressure 86 to 106 KiloPascal; Storage environment humidity 10 to 75 % RH; Storage environment temperature -10 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PHT-90CHO | In distribution | |
| PHT-90CHO | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rayscan | RAY Co., Ltd., | 52 |
| Rayscan Studio | RAY Co., Ltd., | 21 |
| Dental CT Scanner AXR | Alliage S/A Indústrias Médico Odontológica | 15 |
| PaX-i3D Green | Vatech Co., Ltd. | 14 |
| Orthopantomograph™ OP 3D | Palodex Group OY | 11 |
| Sleeve for extraoral X-Ray devices | Sirona Dental Systems Gmbh | 11 |
| SXR / Saevo | Alliage S/A Indústrias Médico Odontológica | 11 |
| X-Mind trium | DE Götzen SRL | 10 |
| Genoray | Genoray Co., Ltd. | 9 |
| Rayscan α-Expert3D | RAY Co., Ltd., | 9 |
| Orthophos SL | Sirona Dental Systems Gmbh | 9 |
| Orthophos XG | Sirona Dental Systems Gmbh | 9 |
Showing 12 of 110. All products under X-Ray, Tomography, Computed, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260093 | 2026-03-31 |
| K243088 | 2025-02-21 |
| K243081 | 2025-02-14 |
| K231796 | 2023-07-19 |
| K210329 | 2021-02-18 |
| K203797 | 2021-01-25 |
| K201627 | 2020-10-27 |
| K170066 | 2017-06-16 |
| K160882 | 2016-10-28 |
| K162660 | 2016-10-20 |
| K152106 | 2015-10-23 |
| K132983 | 2014-08-07 |
| K130432 | 2013-05-31 |
| K121400 | 2012-08-28 |
| K121412 | 2012-06-08 |
| K121236 | 2012-05-24 |
| K102196 | 2011-03-25 |
| K090467 | 2010-01-08 |
| K082350 | 2008-10-10 |
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.