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FractureDetect (FX)

Imagen Technologies, Inc. · Model 1.0.0 · UDI-DI 00852491008016

QBS
1
510(k) clearances
0
Adverse events
0
Recalls
8
Facilities

Description

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.

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Data 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.