Cleerly Labs
K190868Cleerly Inc · cleared 2019-11-05 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“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 and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD.”
source quote (p.9)
“The machine learning algorithms were evaluated by comparing the output of the software to that of the ground truth using multiple ground truthers.”
source quote (p.5)
“Cleerly Labs has implemented security features for device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices".”
Validation studies (3)
Reader study (MRMC)
sample size not stated
endpoints: Pearson Correlation Coefficients; Bland-Altman Agreements; Lumen Volume; Vessel Volume; Total Plaque Volume; Calcified Plaque Volume; Non-Calcified Plaque Volume; Low-Density-Non-Calcified Plaque Volume
standards: NEMA PS 3.1-3.20, ANSI/AAMI/IEC 62304, ISO 14971, ANSI AAMI IEC 62366-1
Bench
sample size not stated
endpoints: clinical acceptability of the device
standards: NEMA PS 3.1-3.20, ANSI/AAMI/IEC 62304, ISO 14971, ANSI AAMI IEC 62366-1
Bench
sample size not stated
endpoints: comparison to an already cleared device with a similar intended use
standards: NEMA PS 3.1-3.20, ANSI/AAMI/IEC 62304, ISO 14971, ANSI AAMI IEC 62366-1
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242338 (decision 2025-03-07) from Cleerly, Inc. for a matching device line ("Cleerly LABS (v2.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242338
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K202280 (decision 2020-10-02) from Cleerly, Inc. for a matching device line ("Cleerly Labs v2.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K202280
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- …and 22 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).