Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

K223106

Brainlab AG · cleared 2023-07-14 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.”

AlgorithmConvolutional Neuronal Network (CNN) developed using a Supervised Learning approach

source quote (p.6)

“The AI/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach.”

Adaptive (vs locked)No

source quote (p.6)

“The training process begins with the model observing, learning, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project.”

PCCPNo

Cybersecurity addressedNo

Validation studies (3)

Bench

sample size not stated

Bench

sample size not stated

Retrospective clinical

sample size not stated

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K243633 (decision 2025-06-13) from Brainlab AG for a matching device line ("Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243633

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).