# K243350: Rapid Neuro3D

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Jan 22, 2025 after 86 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K896095 (1990). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233582: Rapid, Ischemaview, Inc. (2024) Summary page 6.

## Most influential descendants
- K251987: Rapid Aortic Measurements (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K243350
Methodology: https://510kreport.com/methodology