uOmnispace.MI

Validation studies (2)

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.

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K242624 (decision 2025-05-14) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("Medical Image Post-processing Software (uOmnispace.CT)") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K242624

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K233209 (decision 2024-05-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uOmnispace.CT") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K233209

• re_clearance

  The FDA AI/ML device list shows a newer 510(k) K233186 (decision 2024-04-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uOmnispace.MR") — a new clearance for the same line is a change event.

  first seen 2026-07-08 · k_number:K233186

• 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

• …and 23 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.