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Caddie

FDA UDIEUDAMED

Class II (US FDA UDI)

by Odin Medical Limited

Identity

Trade Name
CADDIE FDA UDI
Generic Name
Endoscopic video image interpretive software FDA UDI
Device Name
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. FDA UDI
Model / Reference
v1.4.x FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
15065010840024 FDA UDI
FDA Product Code
QNP FDA UDI
SBX FDA UDI
GMDN Term
Endoscopic video image interpretive software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1520 FDA UDI
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic video image interpretive software

Caddie by Odin Medical Limited — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image interpretive software.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Odin Medical Limited

Sources (2)

  • FDA UDI 422a16ab-08d2-4c25-93bd-a8d66c3ef628 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026