GyriCalc (Version 1.0.0)
K250686NeuroSpectrum Insights Corp. · cleared 2025-07-22 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“GyriCalc is an automated imaging post-processing software medical device (SaMD) that provides automatic labeling, visualization, volumetric quantification, surface area, thickness and gyrification analysis of brain structures for children ages 24-36 months of age from a set of MR images and returns segmented images and morphometric reports.”
source quote (p.10)
“Automatic segmentation and quantification of brain structures using deep learning. GyriCalc's automated segmentation utilizes FreeSurfer's robust SynthSeg algorithm whereas the predicate device uses a dynamic probabalistic neuroanatomical atlas for its automated segmentation functionality.”
source quote (p.15)
“GyriCalc utilizes current 'state of the art' cybersecurity processes and controls which align with FDA's current guidance and recommendations.”
Validation studies (1)
Retrospective clinical
n=82 patients
endpoints: segmentation accuracy (Dice's coefficient); segmentation reproducibility; mean absolute volume error; mean absolute surface area error; mean absolute gyrification index error
Reported performance (1 observation)
source quote (p.23)
“The average Dice score between the predicted volumes of brain subregions and the reference volumes ranged from 0.92 to 0.99, with an average of 0.95 for all regions.”
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
- 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).