THINQ

K192051

CorticoMetrics LLC · cleared 2020-09-30 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“THINQ™ is a software-only, non-interactive, medical device for quantitative imaging, accepting as input 3D T1-weighted MRI scan data of the human head.”
Algorithmatlas-based segmentation of brain structures using a probabilistic neuroanatomical atlas based on the MR image intensity
source quote (p.7)
“Automatic segmentation and quantification of brain structures using a probabilistic neuroanatomical atlas based on the MR image intensity”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

n=645 images

endpoints: Dice similarity coefficient metric; Absolute Percent Difference (APD) metric; Absolute Volume Error (AVE); Relative Volume Error (RVE)

standards: 21 CFR part 820, ISO 13485:2016, ISO 14971:2007, ISO 62304:2006, ISO 62366-1:2015

Bench

n=645 images

endpoints: Absolute Percent Difference (APD) metric

standards: 21 CFR part 820, ISO 13485:2016, ISO 14971:2007, ISO 62304:2006, ISO 62366-1:2015

Reported performance (29 observations)

diceas written: “Whole Brain Dice”0.94CI 0.01
source quote (p.9)
“Dice 0.94 (0.01)”
diceas written: “Total Gray Matter Dice”0.82CI 0.02
source quote (p.9)
“Dice 0.82 (0.02)”
diceas written: “Total White Matter Dice”0.87CI 0.04
source quote (p.9)
“Dice 0.87 (0.04)”
diceas written: “Left Cortical Gray Matter Dice”0.92CI 0.06
source quote (p.9)
“Dice 0.92 (0.06)”
diceas written: “Right Cortical Gray Matter Dice”0.92CI 0.07
source quote (p.9)
“Dice 0.92 (0.07)”
diceas written: “Left Frontal Lobe Dice”0.9CI 0.06
source quote (p.9)
“Dice 0.90 (0.06)”
diceas written: “Right Frontal Lobe Dice”0.9CI 0.06
source quote (p.9)
“Dice 0.90 (0.06)”
diceas written: “Left Parietal Lobe Dice”0.88CI 0.08
source quote (p.9)
“Dice 0.88 (0.08)”
diceas written: “Right Parietal Lobe Dice”0.88CI 0.08
source quote (p.9)
“Dice 0.88 (0.08)”
diceas written: “Left Occipital Lobe Dice”0.82CI 0.07
source quote (p.9)
“Dice 0.82 (0.07)”
diceas written: “Right Occipital Lobe Dice”0.82CI 0.08
source quote (p.9)
“Dice 0.82 (0.08)”
diceas written: “Left Temporal Lobe Dice”0.89CI 0.06
source quote (p.9)
“Dice 0.89 (0.06)”
diceas written: “Right Temporal Lobe Dice”0.89CI 0.06
source quote (p.9)
“Dice 0.89 (0.06)”
diceas written: “Left Cerebral White Matter Dice”0.86CI 0.04
source quote (p.10)
“Dice 0.86 (0.04)”
diceas written: “Right Cerebral White Matter Dice”0.86CI 0.04
source quote (p.10)
“Dice 0.86 (0.04)”
diceas written: “Left Lateral Ventricle Dice”0.86CI 0.07
source quote (p.10)
“Dice 0.86 (0.07)”
diceas written: “Right Lateral Ventricle Dice”0.85CI 0.07
source quote (p.10)
“Dice 0.85 (0.07)”
diceas written: “Left Hippocampus Dice”0.78CI 0.03
source quote (p.10)
“Dice 0.78 (0.03)”
diceas written: “Right Hippocampus Dice”0.79CI 0.03
source quote (p.10)
“Dice 0.79 (0.03)”
diceas written: “Left Amygdala Dice”0.66CI 0.05
source quote (p.10)
“Dice 0.66 (0.05)”
diceas written: “Right Amygdala Dice”0.64CI 0.06
source quote (p.10)
“Dice 0.64 (0.06)”
diceas written: “Left Caudate Dice”0.78CI 0.07
source quote (p.10)
“Dice 0.78 (0.07)”
diceas written: “Right Caudate Dice”0.78CI 0.07
source quote (p.10)
“Dice 0.78 (0.07)”
diceas written: “Left Putamen Dice”0.82CI 0.04
source quote (p.10)
“Dice 0.82 (0.04)”
diceas written: “Right Putamen Dice”0.82CI 0.03
source quote (p.10)
“Dice 0.82 (0.03)”
diceas written: “Left Thalamus Dice”0.82CI 0.03
source quote (p.10)
“Dice 0.82 (0.03)”
diceas written: “Right Thalamus Dice”0.83CI 0.03
source quote (p.10)
“Dice 0.83 (0.03)”
diceas written: “Left Cerebellum Dice”0.91CI 0.02
source quote (p.10)
“Dice 0.91 (0.02)”
diceas written: “Right Cerebellum Dice”0.92CI 0.02
source quote (p.11)
“Dice 0.92 (0.02)”

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
drift signals on this device
  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98137

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97993

  • …and 20 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 2026-07-08.

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 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/K192051