Axial3D Insight

K232841

Axial Medical Printing Limited · cleared 2023-11-15 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.”
Algorithmmachine learning models
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.”
Adaptive (vs locked)No
source quote (p.13)
“AxialML machine learning models were independently verified and validated before inclusion in the Axial3D Insight device.”
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Retrospective clinical

n=12 cases

endpoints: assessment and feedback from the radiologists; scored within the acceptance criteria of 1 or 2a

standards: ACR RADPEER committee white paper with 2016 updates: revised scoring system, new classifications, self-review, and subspecialized reports." Journal of the American College of Radiology 14.8 (2017): 1080-1086.

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=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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232841