TeraRecon Neuro

K220349

TeraRecon, Inc · cleared 2022-08-12 · product code LLZ · Radiology

FDA 510(k) summary for TeraRecon Neuro (K220349)

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
5
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.3)
“The TeraRecon Neuro Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform.”
AlgorithmThe TeraRecon Neuro Algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, rotational MIP 3D batch while removing the skull. This "tumble view" allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review.
source quote (p.3)
“The TeraRecon Neuro Algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, rotational MIP 3D batch while removing the skull. This "tumble view" allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Reader study (MRMC)

sample size not stated

endpoints: confirm through qualitative assessment that the generated maps of TeraRecon Neuro are at least 85% substantially equivalent or better than the predicate and reference devices.

standards: IEC 62304:2006/AI:2015, ISO 14971:2007

Standalone

sample size not stated

endpoints: absolute error for Tmax measurements; absolute percent error for Tmax measurements

standards: IEC 62304:2006/AI:2015, ISO 14971:2007

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
33
drift signals on this device
  • predicate_cohort_contagion

    K220349 shares predicate K182130 with K233209 (uOmnispace.CT), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K182130 sibling:K233209

  • predicate_cohort_contagion

    K220349 shares predicate K182130 with K233512 (Rapid (6.0)), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K182130 sibling:K233512

  • predicate_cohort_contagion

    K220349 shares predicate K193289 with K242624 (Medical Image Post-processing Software (uOmnispace.CT)), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K193289 sibling:K242624

  • 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

  • …and 27 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.

Related FDA clearances

More AI/ML devices under product code LLZ

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/K220349