K-numberK250716
Device nameIMAGE ONE
ApplicantInfomed Software, S.L.
Product codeLLZ
Device classClass II
Decision dateJul 23, 2025
DecisionSubstantially Equivalent
Regulation892.2050
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

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.

Technological characteristics

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).

Test standards cited

Not stated in this summary.

Substantial equivalence argument

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.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?
Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.
Start free trial →

Everything you need for a 510(k) submission. Nothing you don't.

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →