| K-number | K250716 |
| Device name | IMAGE ONE |
| Applicant | Infomed Software, S.L. |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Jul 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
IMAGE ONE is a cloud-based dental imaging software that provides viewer and image processing tools for maxillofacial radiographic images. It allows trained dental professionals to acquire, view, save, and analyze 2D and 3D image files from panoramic, cephalometric, and intra-oral imaging equipment in multiple formats including DICOM, PNG, JPEG, BMP, STL, and MP4.
IMAGE ONE includes zoom functionality (maximum 10x magnification), filter functions (brightness, contrast, color inversion, softening, sharpening, relief), linear distance and angle measurement tools restricted to 2D X-ray images with visible calibrators, and image annotation capabilities. It runs on Google Chrome 100+ on Windows 10+ with SQL Server database compatibility and supports multiple image input and viewing modes (full, gallery, thumbnail).
Not stated in this summary.
IMAGE ONE is substantially equivalent to predicate EzDent Web because both are dental imaging software with identical indications for use—providing viewer and processing tools for DICOM-compliant maxillofacial radiographic images for trained professionals. Both support the same core functions: acquisition, viewing, saving of 2D/3D files, measurement tools (linear distance and angle), and image manipulation. Although IMAGE ONE lacks predicate features like profile measurements and implant libraries, the core technology, intended purpose, and safety profile are materially identical; any minor feature differences do not affect the fundamental image management and visualization function.
View the full FDA submission: accessdata.fda.gov