Axial3D Insight
K232841Axial Medical Printing Limited · cleared 2023-11-15 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.12)
“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.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 (5)
Retrospective clinical
n=12 cases
endpoints: segmentation accuracy (scored within acceptance criteria of 1 or 2a)
standards: ACR RADPEER committee white paper with 2016 updates
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
Standalone
n=48,869 images
Bench
sample size not stated
endpoints: reproduce the required geometry to an acceptance criterion of ± 0.3mm
standards: Slide 12 FDA/CDRH–RSNA SIG Joint Meeting on 3D Printed Patient-Specific Anatomic Models
Bench
sample size not stated
endpoints: produce anatomical models with the required accuracy of the product
Reported performance (1 observation)
source quote (p.15)
“This verification test establishes that the printer can reproduce the required geometry to an acceptance criterion of ± 0.3mm, the same acceptance criteria used to verify the predicate device (Axial 3D Insight, K222745)”
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
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).