CVI42

K141480

CIRCLE CARDIOVASCULAR IMAGING INC · cleared 2014-08-22 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions. It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.”

AlgorithmThe device uses digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP), inverted MIP, volume rendering technique (VRT), curved planner reformation, processing tools for bone removal (single and dual energy), and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images).

source quote (p.3)

“Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images)”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K251027 (decision 2025-10-27) from Circle Cardiovascular Imaging, Inc. for a matching device line ("cvi42 Coronary Plaque Software Application") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251027
re_clearance
The FDA AI/ML device list shows a newer 510(k) K242781 (decision 2024-10-15) from Circle Cardiovascular Imaging Inc. for a matching device line ("cvi42 Software Application") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242781
re_clearance
The FDA AI/ML device list shows a newer 510(k) K213998 (decision 2022-07-28) from Circle Cardiovascular Imaging Inc for a matching device line ("cvi42 Auto Imaging Software Application") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213998
adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
…and 23 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).