Myocardial Strain Software Application

K232661

Circle Cardiovascular Imaging · cleared 2023-12-07 · product code LLZ · Radiology

FDA 510(k) summary for Myocardial Strain Software Application (K232661)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Circle's Myocardial Strain Software Application (Strain Module) is a software device that enables the analysis of CMR images acquired using SSFP cine imaging.”
AlgorithmThe Strain Module implements an algorithm for deformations modeling of topologies that relies on a two-dimensional (2D) version of the nearly incompressible deformable model. The deformation of the model is assumed to be completely determined by a set of control points placed on the middle curve of the myocardial wall; these points are first defined by the end-user in a reference phase, and then detected in all other phases based on the feature tracked boundaries and incompressibility constraint of the model. Once this feature tracking is complete, the Strain Module computes and reports various global and regional deformation quantities such as strains (including Global Longitudinal Strain (GLS) and Global Circumferential Strain (GCS)), strain rates, displacements, velocities, and torsion.
source quote (p.6)
“The Strain Module implements an algorithm for deformations modeling of topologies that relies on a two-dimensional (2D) version of the nearly incompressible deformable model. The deformation of the model is assumed to be completely determined by a set of control points placed on the middle curve of the myocardial wall; these points are first defined by the end-user in a reference phase, and then detected in all other phases based on the feature tracked boundaries and incompressibility constraint of the model. Once this feature tracking is complete, the Strain Module computes and reports various global and regional deformation quantities such as strains (including Global Longitudinal Strain (GLS) and Global Circumferential Strain (GCS)), strain rates, displacements, velocities, and torsion.”
Adaptive (vs locked)No
source quote (p.6)
“Note that the feature tracking and deformation quantity computation is purely mathematical; the Strain Module does not involve any artificial intelligence (AI) or machine learning (ML).”
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: tracking performance; deformation field; computation of the deformation metrics

standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, DICOM standards

Reader study (MRMC)

sample size not stated

endpoints: tracking performance; Global Longitudinal Strain; Global Circumferential Strain

standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, DICOM standards

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
30
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • 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

  • …and 24 more.

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 2026-09-02.

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.

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These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232661