Circle Cardiovascular Imaging

What does cvi42 cover?

The vendor lists modules for Cardiac MR, Cardiac CT, AI Plaque Analysis, Vascular CT, Interventional Planning, Electrophysiology and Acute Stroke. The analysis covers volumes, strain, mapping, calcium and plaque quantification, and StrokeSENS handles acute stroke CT and CTA with ASPECTS, LVO detection and multiphase CTA perfusion. Circle names integrated solutions with GE Healthcare and Siemens Healthineers and claims "600+ OEM deployments worldwide" through distributor relationships. Hospital logos on the site include Mayo Clinic Rochester and Cleveland Clinic.

How are the FDA records split?

The oldest of the twelve is K082628, the CMR42 Cardiac MRI Imaging System, dated November 20, 2008. The cvi42 Coronary Plaque Software Application, K251027, dated October 27, 2025, is the coronary plaque clearance. StrokeSENS LVO, K212261, dated October 14, 2021, is the only record with the triage product code QAS, and it is filed under a separate applicant, Circle Neurovascular Imaging, Inc. StrokeSENS ASPECTS has its own clearance, and TruPlan has two.

What quality and regulatory credentials does the vendor list?

Circle lists ISO 13485:2016 and MDSAP certificates from BSI, effective August 31, 2024, plus IEC 62304, IEC 62366-1 and ISO 14971. It cites a CE mark under EU MDR for cvi42 and StrokeSENS, Health Canada numbers 93385 for cvi42 and 107386 for StrokeSENS, and listings with regulators such as Australia's TGA and Brazil's ANVISA.

How much of the literature tests the software?

PubMed returns 133 results for cvi42, overwhelmingly research papers in which cvi42 is the measurement tool. One derived cardiac MR reference ranges for the Healthy Hearts Consortium with it (PMID 38613554), and another compared aortic valve calcium scoring across 3Mensio, Syngo.via and cvi42. StrokeSENS has three papers of its own: multiphase CTA perfusion against CT perfusion in 121 patients, LVO accuracy on CTA, and a 2026 multi-reader ASPECTS study. No accuracy paper for the K251027 plaque tool appeared in PubMed.

The verdict

The cardiac MR and CT software has the longest record, going back to 2008, and appears across published research as a measurement tool. StrokeSENS has accuracy and reader-study papers, and the coronary plaque tool has none in PubMed. A department choosing for plaque is relying on the FDA clearance and the vendor's description. A department choosing for stroke triage has one QAS-coded product, filed under Circle Neurovascular Imaging, Inc.