"The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s mouth just like a silver fi lm) captures the X-rays…
“The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s mouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen. All the images captured with the SOPIX series system can be recalled onto the screen with the Sopro Imaging software provided with the system. This software manages the display, processing and storage of images taken with the SOPIX series system. A.C.E™ (Automatic Control Exposure) technology, patented by SOPRO, provides the system with outstanding features. In real time it analyses the quantity of energy received by the sensor, which fi xes the image acquisition once it has received the energy needed to produce a good-quality image. As a result, every image is protected against overexposure.”
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 Acteon | Listed by | Sopro, France |
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K151053 |
| Record published | 2018-11-19 |
| Record revised | 2024-07-25 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.