Careverse CoronaryDoc (Careverse CoronaryDoc)

K251656

Careverse Technology Pte. Ltd. · cleared 2025-09-04 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Careverse CoronaryDoc is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD.”
Algorithmautomatically extracts the coronary region, detects suspected stenosis lesions in this area, and further performs automatic plaque analysis. At the same time, the software can also automatically detect stents and bridges.
source quote (p.6)
“Based on the axial image data of coronary computed tomography angiography (CCTA), Careverse CoronaryDoc automatically extracts the coronary region, detects suspected stenosis lesions in this area, and further performs automatic plaque analysis. At the same time, the software can also automatically detect stents and bridges.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“Guiding Principles for Cybersecurity Registration Review of Medical Devices (2022)”

Validation studies (1)

Retrospective clinical

n=1,116 other

endpoints: segmentation performance; labeling performance; stenosis performance; plaque performance

standards: ISO 14971:2019 "Medical devices - Application of risk management to medical devices", ISO/TR 24971:2020 "Medical Device Software GB/T42062 Application Guide", ISO 13485:2016 "Medical devices – Quality management systems – Requirements for use in regulations", IEC 62304:2015, GB/T 25000.51-2016 "Systems and software engineering - Quality requirements and evaluation of systems and software (SQuaRE) Part 51: Quality requirements and test rules for ready-to-use software products (RUSP), General Principles of Software Validation; Final Guidance for Industry and FDA Staff, CDRH and FDA, Jan. 11, 2012, Guiding Principles for Cybersecurity Registration Review of Medical Devices (2022), Guidelines for On-site Inspection of Independent Software in Good Manufacturing Practice for Medical Devices (2020)

Reported performance (3 observations)

diceas written: “Dice Coefficient (segmentation)”0.899
source quote (p.9)
“The value of Dice Coefficient is 0.899, which is higher than the acceptable criteria 0.842.”
accuracyas written: “Labeling accuracy on case level”93.1
source quote (p.9)
“For the labeling performance, the accuracy on case level is 93.10%”
accuracyas written: “Labeling accuracy on vessel level”98.21
source quote (p.9)
“the accuracy on vessel level is 98.21%.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251656