AIRAscore
K223180AIRAmed GmbH · cleared 2023-08-25 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“AIRAscore is a software as medical device (SaMD) that runs on AIRAmed internal servers (Software as a Service - SaaS).”
source quote (p.6)
“Segmentation by machine learning (supervised voxel classification by a Convolutional Neuronal Network)”
source quote (p.5)
“segmentation is performed using specialized neuronal networks that remain static during the lifetime of a software version.”
source quote (p.8)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014 Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, 2005”
Validation studies (3)
Standalone
sample size not stated
endpoints: Brain segmentable structure volumes / volume changes
Bench
sample size not stated
endpoints: Brain segmentable structure volumes / volume changes compared on test-retest images
Bench
sample size not stated
standards: ISO 14971:2019 Medical devices - Application of risk management to medical devices, IEC 62304 Edition 1.1 2015-06 Medical device software - Software life-cycle processes, IEC 62366-1 Edition 1.0 2015-02 Medical devices - Application of usability engineering to medical devices, CFR 21 part 820 Quality System Regulation for Medical Devices, ISO 13485:2016 Medical devices - Quality management systems, NEMA PS 3.1 - 3.20 (2016) Digital imaging and communication in medicine (DICOM) Set, ISO 14971 Third Edition 2019-12 - Medical Devices - Application Of Risk Management To Medical Devices, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION - Medical Device Software - Software Life Cycle Processes
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
- 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).