Overjet Image Enhancement Assist
K241681Overjet Inc · cleared 2024-09-09 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Overjet Image Enhancement is a Software as a Medical Device (SaMD) that enhances dental radiographic images within the Overjet Platform”
source quote (p.5)
“The software enhances image quality by reducing noise with a learning-based algorithm for bitewing and periapical images, and by improving contrast and sharpness using standard, non-learning based techniques. For panoramic images, standard enhancement techniques improve contrast and sharpness without learning-based noise reduction.”
source quote (p.6)
“The subject device uses one model for denoising with standard techniques for sharpness and contrast, while the predicate uses two learning based models. Both devices utilize the PyTorch framework and similar loss functions, and these differences do not raise new questions of safety and effectiveness.”
Validation studies (1)
Retrospective clinical
sample size not stated
endpoints: contrast-to-noise ratio (CNR); peak-signal-to-noise ratio (PSNR); Likert expert clinical evaluation
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).