NemoScan

K232698

Software Nemotec S.L. · cleared 2024-01-18 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“NemoScan is a comprehensive diagnosis and treatment planning software for dental implantology intended to be used by dental professionals who have appropriate knowledge in surgical implantology and dental implants prosthesis.”

AlgorithmThe software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. Functions include patient gums, teeth, bones, mandibular nerves and sinus segmentation and bone densitometry with a density statistic.

source quote (p.5)

“The software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. Patient gums, teeth, bones, mandibular nerves and sinus segmentation to help the planner in viewing those anatomical conditions in 3D and their corresponding cross sections in the 2D slices. Bone densitometry with a density statistic for density measuring in the area around a distance outside and inside the limits of the positioned implant.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: assure a guide of a certain material can safely and effectively be manufactured

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).