Axial3D Insight
K222745Axial Medical Printing Limited · cleared 2023-07-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Axial3D Insight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file.”
source quote (p.13)
“AxialML machine learning models are used to generate an initial segmentation of cases, however the output of these models is not used in isolation to produce the final 3D patient specific model.”
source quote (p.13)
“AxialML machine learning models are used to generate an initial segmentation of cases, however the output of these models is not used in isolation to produce the final 3D patient specific model. The segmentations produced by the AxialML machine learning models are used by Axial3D trained staff who complete the final segmentation and validation of the quality of each 3D patient specific model produced.”
source quote (p.6)
“Axial3D Insight is a secure, highly available cloud-based image processing, segmentation and 3D modelling framework for the transfer of imaging information either as a digital file or as a 3D printed physical model.”
Validation studies (3)
Retrospective clinical
n=12 cases
endpoints: all cases were scored within the acceptance criteria of 1 or 2a [1]
Retrospective clinical
n=12 cases
endpoints: successful validation of the 3D models produced by Axial3D demonstrating the device outputs satisfied end user needs and indications for use
Bench
n=38,870 images
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250369 (decision 2025-09-18) from Axial Medical Printing Limited for a matching device line ("Axial3D Insight") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250369
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232841 (decision 2023-11-15) from Axial Medical Printing Limited for a matching device line ("Axial3D Insight") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232841
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).