CardioLogs ECG Analysis Platform

K170568

Cardiologs Technologies · cleared 2017-06-26 · product code DPS · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.8)
“the Subject device incorporates a logical update to that technology as a software program running on a cloud-based software platform.”
AlgorithmAn automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis. It performs delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal) and provides abnormality labels with probability scores on a predefined set of abnormality labels (multi-label classification). The algorithm is written in Python language.
source quote (p.4)
“An automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis. Delineation (detection of at least P waves, QRS complexes and T waves on the ECG signal). The output format is a sequence of elements “wave type/start time/ end time”; Abnormality labels: the algorithm provides probability scores on a predefined set of abnormality labels (multi-label classification); an automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide supportive information for ECG diagnosis, written in Python language.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Indeed, the Subject devise is cloud-based and available online, implying different cybersecurity, safety and effectiveness question.”

Validation studies (1)

Retrospective clinical

sample size not stated

standards: AAMI ANSI IEC 62304 2006 - Medical device software - Software life-cycle processes, IEC EN 60601-2-25 Edition 2.0 2011-10 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs-, IEC 62366-1 Edition 1.0 2015-02 - Medical devices - Application of usability engineering to medical devices., AAMI ANSI EC57:2012 - Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms, AAMI ANSI IEC60601-2-47:2012 - Medical Electrical Equipment -- Part 2-47: Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems

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

9
recalls in product code, 24mo
72
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
3
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Braemar Manufacturing, LLC, initiated 2024-12-18): "Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95837

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Baxter Healthcare Corporation, initiated 2024-10-11): "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95559

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Schiller, Ag Altgasse 68 Baar Switzerland, initiated 2024-07-24): "Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95074

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 Cardiovascular 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/K170568