Segmentron Viewer
DGNCT LLC · Model 1.0 · UDI-DI 00860010268087
1
510(k) clearances
10
Adverse events
2
Recalls
236
Facilities
Description
Segmentron Viewer is a software product intended for processing and manipulating maxillofacial radiographic images. Segmentron Viewer allows users to perform the following functions: Viewing patient images (provides tools for image processing and viewing functions); Reading and 3D visualization of CBCT images Generating editable 3D STL files (for educational purposes only). The device is indicated for use by medical professionals (such as dentists and radiologists), in patients 14 years and older with permanent teeth. Segmentron Viewer is a web application. It can be used in a network environment.
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.