Rapid Neuro3D

Rapid Neuro3D (RN3D) is an image analysis software for imaging datasets acquired with

conventional CT Angiography (CTA) from the aortic arch to the vertex of the head. The module

removes bone, tissue, and venous vessels, providing a 3D and 2D visualization of the

neurovasculature supplying arterial blood to the brain.

Outputs of the device include 3D rotational maximum intensity projections (MIPS), volume renders

(VR), along with the curved planar reformation (CPR) of the isolated left and right internal carotid

and vertebral arteries.

Rapid Neuro3D is designed to support the physician in confirming the presence or absence of

physician-identified lesions and evaluation, documentation, and follow-up of any such lesion and

treatment planning.

Its results are not intended to be used on a stand-alone basis for clinical decision-making or

otherwise preclude clinical assessment.

RN3D is indicated for adults.

Precautions/Exclusions:

o Series containing excessive patient motion or metal implants may impact module output quality.

o The RN3D module will not process series that meet the following module exclusion criteria:

* Series containing inadequate contrast agent (<0.3 mL of right-hemisphere intracranial arterial

contrast media or <0.3 mL of left-hemisphere intracranial arterial contrast media, above 120 HU)

* Series acquired w/cone-beam CT scanners (c-arm CT)

» Series that are non-axial

Series with a non-supine patient position

* Series containing missing or improperly ordered slices (e.g., as a result of manual correction by

an imaging technician)

* CTA datasets with:

1) in-plane X and Y FOV < 160mm or > 400mm.

2) Z FOV (cranio-caudal transverse anatomical coverage) < 90 mm.

3) in-plane pixel spacing (X & Y resolution) < 0.2 mm or > 1.0 mm.

4) Z slice spacing of < 0.2 mm or > 1.25 mm.

5) slice thickness > 1.5mm.

6) data acquired at x-ray tube voltage < 70kVp or > 150kVp.