Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“nordicMEDIVA is a software as a medical device (SaMD) for processing of MR images of the brain.”

Algorithmrule-based algorithms for the calculation of metrics from dynamic MRI data

source quote (p.5)

“The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.”

Adaptive (vs locked)No

source quote (p.5)

“The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.”

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“Cybersecurity considerations related to nordicMEDIVA are included within this submission. nordicMEDIVA conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.”

Validation studies (4)

Bench

sample size not stated

endpoints: All scenarios from the summative usability test met the acceptance criteria completely, no new risks were found and existing risk control measures were proven to be effective.

standards: ISO 14971 Medical devices - Application of risk management to medical devices, IEC 62304 Medical device software - Software life cycle processes, IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Health software - Part 1: General requirements for product safety

Bench

sample size not stated

endpoints: The results from Diffusion and Tractography were evaluated in comparison with equivalent results from the predicate device, nordicBrainEx (K163324). The results were reviewed by internal and external clinical experts and proven to be as effective as the predicate device

standards: ISO 14971 Medical devices - Application of risk management to medical devices, IEC 62304 Medical device software - Software life cycle processes, IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Health software - Part 1: General requirements for product safety

Bench

sample size not stated

endpoints: The results from BOLD fMRI were evaluated in comparison with equivalent results from the predicate device, nordicBrainEx (K163324). The results were reviewed by internal and external clinical experts and proven to be as effective as the predicate device

standards: ISO 14971 Medical devices - Application of risk management to medical devices, IEC 62304 Medical device software - Software life cycle processes, IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Health software - Part 1: General requirements for product safety

Bench

sample size not stated

endpoints: The results from the DSC was confirmed to be the same as the reference device nordicMEDIVA (K241608) where a Lin's Concordance Correlation Coefficient of enhancing voxels was calculated with acceptance criteria being greater than or equal to 0.8 was applied.

standards: ISO 14971 Medical devices - Application of risk management to medical devices, IEC 62304 Medical device software - Software life cycle processes, IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Health software - Part 1: General requirements for product safety

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

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).