PaX-i3D Green Premium / Green 21
Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray Image data…
Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray Image data (Xmaru3104CF)
4manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
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 |
| Record published | 2017-06-30 |
| Record revised | 2024-02-19 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCT-90LH | 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.