PaX-i
Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 1210SGA)
10manufacturers in China registered for this device type
7catalogue numbers in this listing
8510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shanghai Handy Medical Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Vatech Co., Ltd., South Korea |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2024-03-18 (version 3) |
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 |
| Distribution end date | 2024-03-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCH-2500 | In distribution | |
| PCH-2500 | In distribution | |
| PCH-2500 | Withdrawn | |
| PCH-2500 | Withdrawn | |
| PCH-2500 | Withdrawn | |
| PCH-2500 | Withdrawn | |
| PCH-2500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Schick Elite | Sirona Dental, Inc. | 38 |
| Schick Wifi | Sirona Dental, Inc. | 31 |
| Midmark Intraoral Digital Sensor | Midmark Corporation | 26 |
| Xios XG Wifi | Sirona Dental, Inc. | 25 |
| Midmark OptiMax Digital Sensor System | Midmark Corporation | 24 |
| Gendex GXS-700™ intraoral sensor | Gendex Corp. | 19 |
| Genoray | Genoray Co., Ltd. | 14 |
| X-Mind trium | DE Götzen SRL | 12 |
| X-Mind optima 3D | DE Götzen SRL | 12 |
| Dexis Titanium Sensor Kit | Dental Imaging Technologies Corporation | 11 |
| Xios XG Select | Sirona Dental, Inc. | 11 |
| Planmeca ProMax | Planmeca Oy | 11 |
Showing 12 of 279. All products under System, X-Ray, Extraoral Source, Digital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240040 | 2024-10-25 |
| K170731 | 2017-04-04 |
| K130585 | 2013-07-15 |
| K122155 | 2012-09-04 |
| K113672 | 2012-03-27 |
| K102124 | 2010-10-22 |
| K100317 | 2010-03-24 |
| K073365 | 2008-04-08 |
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.