# K250288: TeraRecon Cardiovascular.Calcification.CT

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Oct 23, 2025 after 265 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: 12 generations back to K954355 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233211: Aview Cac, Coreline Soft Co., Ltd. (2024) Summary page 5.

## Indications for use
TeraRecon Cardiovascular.Calcification.CT is intended to provide an automatic 3D segmentation of calcified plaques within the coronary arteries and outputs a mask for calcium scoring systems to use for calculations. The results of TeraRecon Cardiovascular.Calcification.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Cardiovascular.Calcification.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT heart without contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems. The device does not alter the original input data and does not provide a diagnosis. TeraRecon Cardiovascular.Calcification.CT is indicated to generate results from Calcium Score CT scans taken of adult patients, 30 years and older, except patients with pre-existing cardiac devices, electrodes, previous and established ischemic diseases (IMA, bypass grafts, stents, PTCA) and Thoracic metallic devices. The device is not specific to any gender, ethnic group, or clinical condition. The device's use should be limited to CT scans acquired on General Electric (GE) or Siemens Healthcare or their subsidiaries (e.g. GE Healthcare) equipment. Use of the device with CT scans from other manufacturers is not recommended.

Source page: https://510kreport.com/device/K250288
Methodology: https://510kreport.com/methodology