Cleerly LABS (v2.0)

K242338

Cleerly, Inc. · cleared 2025-03-07 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Cleerly LABS 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.”
Algorithmmachine learning and deep learning methodology
source quote (p.6)
“Cleerly LABS utilizes machine learning and simple rule-based mathematical calculation components which are performed on the backend of the software. The software applies deep learning methodology to identify high quality images, segment and label coronary arteries, and segment lumen and vessel walls.”
Adaptive (vs locked)No
source quote (p.7)
“In addition, the core functions of Cleerly LABS are supported by artificial intelligence, nonadaptive machine learning algorithms for CCTA processing and analysis.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“The device has been designed to meet the requirements associated with ISO 14971, 2019-12, Medical Devices – Application of Risk Management to Medical Devices and AAMI TIR 57:2016, Principles for medical device security – Risk management.”

Validation studies (1)

Bench

sample size not stated

standards: ISO 14971, 2019-12, AAMI TIR 57:2016, DICOM, ANSI AAMI IEC 62304:2005/A1:2016

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

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

cat i2026-01-01

CPT 75577 (bare code — descriptor at CMS source) · MPFS rate $1,012.05

New 2026 Category I code for software-derived quantification/characterization of coronary atherosclerotic plaque from CCTA, replacing deleted Category III codes 0623T-0626T. The $1,012.05 figure is the CY2026 MPFS non-facility global payment (physician offices / imaging centers); the K-number maps to Cleerly LABS but the code is billed across AI-QCT plaque vendors. Descriptor at the CMS/AMA source.

Cleerly 2026 billing guideCaristo — CY2026 PFS and OPPS finalizedACC Coding Corner — 75577 replaces 0623T-0626T

cat i2026-01-01

CPT 75577 (bare code — descriptor at CMS source) · OPPS rate $950.5

Hospital-outpatient companion to the 75577 MPFS payment: the CY2026 OPPS final rule places 75577 in APC 1511 (status S) at $950.50. Reported separately from the MPFS figure. Effective with the code on 2026-01-01.

Cleerly 2026 billing guide — APC 1511 $950.50HeartFlow reimbursement page (2026 final)

1 payer coverage policy reference this clearance or its codes.

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/K242338