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, automated QA checks, classifier to filter incorrect reports
source quote (p.6)
“The THINQ™ processing pipeline performs an atlas-based segmentation of brain structures followed by measurement of those structures and a comparison to a reference dataset. The pipeline includes automated QA checks on the input DICOM 3D T1 MRI series to ensure adherence to imaging sequence requirements, checks on the data elements generated during the processing pipeline, and usage of a classifier to filter potentially incorrect reports due to corrupted image input.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

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 - Quality System Regulation / Medical Device Good Manufacturing Practices, ISO 13485:2016 – Medical devices – Quality management systems, ISO 14971:2007 – Medical devices – Application of risk management to medical devices, ISO 62304:2006 – Medical device software – Software life-cycle processes, ISO 62366-1:2015 – Medical devices – Part 1: Application of usability engineering to medical devices

Bench

sample size not stated

endpoints: Absolute Percent Difference (APD) metric

standards: 21 CFR part 820 - Quality System Regulation / Medical Device Good Manufacturing Practices, ISO 13485:2016 – Medical devices – Quality management systems, ISO 14971:2007 – Medical devices – Application of risk management to medical devices, ISO 62304:2006 – Medical device software – Software life-cycle processes, ISO 62366-1:2015 – Medical devices – Part 1: Application of usability engineering to medical devices

Reported performance (1 observation)

diceas written: “Whole Brain Dice”0.94CI 0.01
source quote (p.9)
“Table 1 lists the results, including the Absolute Volume Error (AVE) and Relative Volume Error (RVE) metrics.”

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). 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K192051