CorInsights MRI

K193287

ADM Diagnostics, Inc. · cleared 2020-11-20 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“CorInsights MRI is a fully automated MR medical image processing software intended for automatic labeling, visualization and volumetric quantification of identifiable brain structures from DICOM formatted magnetic resonance images.”
Algorithmproprietary automated internal process that includes artifact correction, atlas-based segmentation, volume calculation, and report generation.
source quote (p.5)
“The architecture has a proprietary automated internal process that includes artifact correction, atlas-based segmentation, volume calculation, and report generation.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (6)

Retrospective clinical

n=80 patients

endpoints: IntraClass Correlation coefficient; DICE coefficient; mean absolute percentage difference

standards: FDA's guidance document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", DICOM NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

Retrospective clinical

n=80 patients

endpoints: IntraClass Correlation coefficient; DICE coefficient; mean absolute percentage difference

standards: FDA's guidance document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", DICOM NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

Retrospective clinical

n=70 patients

endpoints: IntraClass Correlation coefficient; DICE coefficient; mean absolute percentage difference

standards: FDA's guidance document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", DICOM NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

Bench

n=1 patients

endpoints: average IntraClass Correlation coefficient; DICE coefficient; mean absolute percentage difference range; average mean absolute percentage difference

standards: FDA's guidance document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", DICOM NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

Retrospective clinical

n=600 patients

endpoints: Development of a reference database

standards: FDA's guidance document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", DICOM NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

Retrospective clinical

n=1,100 patients

endpoints: Comparison of CorInsights MRI values to percentile and z-score ranges expected based on published literature

standards: FDA's guidance document entitled “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", DICOM NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set

Reported performance (13 observations)

agreement_kappaas written: “Hippocampal volume IntraClass Correlation coefficient”0.95
source quote (p.6)
“CorInsights MRI measured hippocampal volume with an IntraClass Correlation coefficient of 0.95”
diceas written: “Hippocampal volume DICE coefficient left”0.83CI standard deviation 2.5%
source quote (p.6)
“DICE coefficient of 83% left (standard deviation 2.5%)”
diceas written: “Hippocampal volume DICE coefficient right”0.83CI standard deviation 2.7%
source quote (p.6)
“83% right (standard deviation 2.7%)”
agreement_kappaas written: “Total gray volume IntraClass Correlation coefficient”0.99
source quote (p.6)
“CorInsights MRI measured total gray volume with an IntraClass Correlation coefficient of 0.99”
diceas written: “Total gray volume DICE coefficient”0.95CI standard deviation 1.6%
source quote (p.6)
“a DICE coefficient of 95% (standard deviation 1.6%)”
diceas written: “Cortical subregions DICE coefficients”stated without valueCI ranging from 81-93%
source quote (p.6)
“CorInsights MRI measured cortical subregions with DICE coefficients ranging from 81-93%”
agreement_kappaas written: “ICV IntraClass Correlation coefficient”0.89
source quote (p.6)
“CorInsights MRI measured ICV with an IntraClass Correlation coefficient of 0.89”
diceas written: “ICV DICE coefficient”0.95CI standard deviation 1.1%
source quote (p.6)
“a DICE coefficient of 95% (standard deviation 1.1%)”
agreement_kappaas written: “Ventricular IntraClass Correlation coefficient”0.98
source quote (p.6)
“CorInsights MRI measured ventricular accuracy with an IntraClass Correlation coefficient of 0.98 (left and right)”
diceas written: “Ventricular DICE coefficient left”0.88CI standard deviation 5.2%
source quote (p.6)
“a DICE coefficient of 88% left (standard deviation 5.2%)”
diceas written: “Ventricular DICE coefficient right”0.87CI standard deviation 5.6%
source quote (p.6)
“87% right (standard deviation 5.6%)”
agreement_kappaas written: “Reproducibility average IntraClass Correlation coefficient”0.97
source quote (p.7)
“average IntraClass Correlation coefficient of 0.97”
diceas written: “Reproducibility DICE coefficient”0.89CI standard deviation 4.0%
source quote (p.7)
“a DICE coefficient of 89% (standard deviation 4.0%)”

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/K193287