CADDIE

Primary DI
05065010840065
Brand
CADDIE
Company
ODIN MEDICAL LIMITED
Model
v1.5.x
Device 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.
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QNPGastrointesinal Lesion Software Detection System
SBXSoftware For Endoscopy Procedure Metrics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNPGastrointesinal Lesion Software Detection SystemGastroenterology, Urology2
SBXSoftware For Endoscopy Procedure MetricsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15065010840024PreviousGS10
05065010840065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506501084002415065010840024
05065010840065050650108400655065010840065

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image interpretive softwareAn interpretive software program intended to be used to analyse endoscopic video images to detect and localize suspected abnormalities (e.g., polyps) in real-time or post-endoscopy [traditional or capsule endoscopy]; it may in addition be intended to differentiate lesions and/or produce a probability score (e.g., neoplastic versus non-neoplastic). It is intended to be used on an off-the-shelf computerized device (e.g., laptop, smartphone), interface with an endoscopic video image processing unit, and will typically apply artificial intelligence (AI)/deep learning techniques to identify abnormalities and overlay visual flags on video images displayed by a monitor.

Regulatory Flags#

DUNS number
224363350
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15065010840024CADDIEv1.4.x2024-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290020140012MAGENTIQ-COLO (ME-APDS)MAGENTIQ EYE LTDQNP2025-08-21
08055060110376ColonPRO™ 4.0LINKVERSE SRLQNP2025-04-01
78055060110375ColonPRO™ 4.0LINKVERSE SRLQNP2025-04-01
08055060110345ColonPRO™ 4.0LINKVERSE SRLQNP2024-10-14
78055060110344ColonPRO™ 4.0LINKVERSE SRLQNP2024-10-14
00860010168417SKOUT systemIterative Scopes, Inc.QNP2024-10-10
15065010840024CADDIEODIN MEDICAL LIMITEDSBX2024-10-01
15065010840024CADDIEODIN MEDICAL LIMITEDQNP2024-10-01
08055060110338GI Genius™ Module 300LINKVERSE SRLQNP2024-09-22
08055060110291ColonPRO™ 4.0LINKVERSE SRLQNP2024-02-26
78055060110290ColonPRO™ 4.0LINKVERSE SRLQNP2024-02-26
08055060110314GI Genius™ Module 100LINKVERSE SRLQNP2024-02-26
08055060110321GI Genius™ Module 200LINKVERSE SRLQNP2024-02-26
04547410541199FUJIFILMFUJIFILM CORPORATIONQNP2024-02-16
10884521844537GI GeniusCovidien LPQNP2023-09-18
10884521844544GI GeniusCovidien LPQNP2023-09-18
08055060110178USB K-switchLINKVERSE SRLQNP2023-08-11
08055060110185FootswitchLINKVERSE SRLQNP2023-08-11
00860010168400SKOUT systemIterative Scopes, Inc.QNP2023-05-23
06973770840012EndoScreenerChengdu Wision Medical Device Co., Ltd.QNP2022-04-26
10884521821545GI GeniusCovidien LPQNP2021-11-20
10884521807259GI GeniusCovidien LPQNP2021-04-30