ScanX Intraoral for Centralized Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be…
ScanX Intraoral for Centralized Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
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.
Record
Regulatory record for ScanX Intraoral for Centralized Imaging | Listed by | AIR Techniques, Inc., United States |
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K013893 |
| Record published | 2016-09-23 |
| Record revised | 2018-08-23 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 80 % RH; Storage environment temperature -29 to 33 °C |
| Packaging | Box |
| Sizes | Height 16 in; depth 15.5 in; width 15.5 in; weight 44 lb |
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.