Caddie

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…

Registry build 21.09.26

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.

1manufacturer
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Registered in Sichuan.

Chinese manufacturers registered for FDA product code QNP
Manufacturer City Province Registered as Device types
Chengdu Wision Medical Device Co., Ltd. Chengdu Sichuan Manufacturer 1

Record

Regulatory record for Caddie
Listed by Odin Medical Limited, United Kingdom
FDA product code QNP
Device type Gastrointesinal Lesion Software Detection System
Device class Class 2
Regulation 21 CFR 876.1520
Establishment Manufacturer
Record published 2025-10-16
Record revised 2024-12-18 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Caddie
Catalogue number Size Status
v1.5.x In distribution
v1.4.x In distribution

Same Product Code

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Product Sold by Catalogue numbers
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Fujifilm Fujifilm Corporation 1
USB K-switch Linkverse SRL 1
GI Genius™ Module 300 Linkverse SRL 1
Footswitch Linkverse SRL 1
ColonPRO™ US Linkverse SRL 1
GI Genius™ Module 100 Linkverse SRL 1
Magentiq-Colo (ME-Apds) Magentiq EYE Ltd 1
EndoScreener Chengdu Wision Medical Device Co., Ltd. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K252586 2025-09-12
K240044 2024-07-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer