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CADDIE

ODIN MEDICAL LIMITED · Model v1.5.x · UDI-DI 05065010840065

QNPSBX Prescription
10
510(k) clearances
2
Adverse events
0
Recalls
13
Facilities

Description

CADDIE is cloud based artificial intelligence medical device standalone software. CADDIE interfaces with the video feed generated by an endoscopic video processor during colonoscopy. CADDIE also includes a Cecum AI feature as an additional convenience function that prompts the user to verify that the CADDIE detection mode is enabled before inspection begins. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.