CADDIE— 510(k) K260133
Substantially EquivalentOdin Medical Limited
FDA 510(k) clearance K260133 for CADDIE, Substantially Equivalent on 2026-09-12. Applicant: Odin Medical Limited. Device class: 2.
Summary
CADDIE is computer-aided detection software for GI endoscopy. Its product code, QNP, covers computer-assisted detection devices used with endoscopy that bring attention to images to aid in detecting lesions in the gastrointestinal tract.
Class II under 21 CFR 876.1520, reviewed by the Gastroenterology and Urology panel. Odin Medical filed it as a Special 510(k).
Review took 239 days (January 16 to September 12, 2026). Odin Medical filed from London, United Kingdom.
Clearance details
- Applicant
- Odin Medical Limited
- Product code
- Product code QNP
- Device class
- Class 2
- Regulation
- 21 CFR 876.1520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- London, GB
Recent devices under product code QNP
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