AudaxCeph Cephalogram Analysis Software
K243005Audax d.o.o. · cleared 2025-05-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“AudaxCeph Cephalogram Analysis Software is a software-only device intended for use by specialty dental professionals in the development of 2D dental treatment planning utilizing cephalogram landmarks.”
source quote (p.6)
“The technological principle for both the subject AudaxCeph Cephalogram Analysis Software and predicate CephX Cephalometric Analysis Software (K231396) is to utilize computer software to digitize landmark placement and measurement tasks. To verify the accuracy of automatically placed landmarks, first an acceptance criteria study was performed to assess the accuracy of manual landmark placement. The results of that study, combined with a literature review of other studies, was used to establish the acceptance criteria upon which automatic landmark detection accuracy was evaluated. The accuracy study involved automatically-detected landmarks reviewed by orthodontists.”
source quote (p.9)
“FDA Guidance (09-27-2023) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions AAMI TIR57:2016 Principles for medical device security - Risk management.”
Validation studies (1)
Bench
sample size not stated
endpoints: automatic landmark detection accuracy; MRE (mm) Lateral; MRE (mm) Frontal (PA)
standards: IEC 62304 ed. 1.1, IEC 62366-1 ed 1.1, ISO 14971:2019, IEC TR 80002-1 ed. 1.0, FDA Guidance (09-27-2023), AAMI TIR57:2016
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).