TOMTEC-ARENA
K201632TOMTEC Imaging Systems GmbH · cleared 2020-08-14 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data.”
source quote (p.7)
“3D surface model is created automatically using machine learning algorithms without user interaction.”
Validation studies (2)
Bench
sample size not stated
endpoints: Completion of all verification activities demonstrated that the subject device meets all design and performance requirements.
standards: IEC 62304 “Medical device software - Software life-cycle processes”
Bench
sample size not stated
endpoints: TOMTEC-ARENA has been found to be safe and effective for the intended users, uses, and use environments.
standards: FDA's Guidance for Industry and FDA Staff “Applying Human Factors and Usability Engineering to Medical Devices", IEC 62366-1 “Medical devices Part 1: Application of usability engineering to medical devices”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K213544 (decision 2022-01-06) from TOMTEC Imaging Systems GmbH for a matching device line ("TOMTEC-ARENA") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213544
- 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
- …and 21 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).