CADDIE

GUDID 15065010840024

CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. 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. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.

ODIN MEDICAL LIMITED

Endoscopic video image interpretive software

• Primary Device ID: 15065010840024
• NIH Device Record Key: 422a16ab-08d2-4c25-93bd-a8d66c3ef628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CADDIE
• Version Model Number: v1.4.x
• Company DUNS: 224363350
• Company Name: ODIN MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com
• Phone: 9999999999
• Email: cs@odin-vision.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15065010840024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240044

FDA Product Code

• QNP: Gastrointesinal Lesion Software Detection System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-09
• Device Publish Date: 2024-10-01