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uOmnispace
Shanghai United Imaging Healthcare Co., Ltd. · Model uOmnispace.MR · UDI-DI 06971576834259
QIH
Prescription
1
510(k) clearances
10
Adverse events
2
Recalls
236
Facilities
Description
Medical Image Post-processing Software
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | PIE Medical Imaging B.V. | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d |
| 2021-05-19 | Caption Health | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.