# K251987: Rapid Aortic Measurements

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Sep 23, 2025 after 88 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: 16 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243350: Rapid Neuro3D, Ischemaview, Inc. (2025) Summary page 5.

## Indications for use
Rapid Aortic Measurements (AM) is an image analysis and measurement device to evaluate aortic and iliac arteries in contrast enhanced and non-contrast CT imaging datasets acquired of the chest, abdomen, and/or pelvis. The module segments the aorta, iliacs, and major branching vessels and provides 2D and 3D visualizations of the segmented vessels. Outputs of the device include: Centerline measurements of the aorta and iliacs, Aortic Zone Measurements (Maximum Oblique Diameter), Fixed Measurements of the aorta and left and right iliacs, 3D Volume Renderings, Rotations, Curved Planar Reformations (CPRs) of the isolated left and right iliacs, aortic oblique Multiplanar Reconstructions (MPRs), and Longitudinal Tracking visualizations. Rapid Aortic Measurements is an aid to physician decision making. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment. Rapid Aortic Measurements is indicated for adults. Precautions/Exclusions: o Series containing excessive patient motion or metal implants may impact module output quality. o The AM module will not process series that meet the following module exclusion criteria: * Series acquired w/cone-beam CT scanners (c-arm CT) * Series that are non-axial or axial oblique greater than 5 degrees * Series containing improperly ordered or missing slices where the gap is larger than 3 times the median inter-slice distance (e.g., as a result of manual correction by an imaging technician) * Series with less than 3cm of target anatomical zones (e.g. aorta or right/left iliac artery) * NCCT, CECT, CTA, or CTPA datasets with: 1) in-plane X and Y FOV < 160mm 2) Z FOV (cranio-caudal transverse anatomical coverage) < 144 mm. 3) in-plane pixel spacing (X & Y resolution) < 0.3 mm or > 1.0 mm. 4) inter-slice distance of < 0.3 mm or > 3 mm. 5) slice thickness > 3 mm. 6) data acquired at x-ray tube voltage < 70kVp or > 150kVp, including single energy, dual energy, or virtual monochromatic datasets

Source page: https://510kreport.com/device/K251987
Methodology: https://510kreport.com/methodology