FDA.reportPublic FDA data

ColonPRO™ 4.0

Primary DI
08055060110345
Brand
ColonPRO™ 4.0
Company
LINKVERSE SRL
Model
4.0.1
Catalog number
CPRO401-US
Device description
Software to be used in GI Genius™ systems.
Published
2024-10-14
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNPGastrointesinal Lesion Software Detection SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241887000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241887000GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)Cosmo Artificial Intelligence - Ai, Ltd.2024-07-25QNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
78055060110344PackageGS17In Commercial Distribution
08055060110345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
7805506011034478055060110344
08055060110345080550601103458055060110345

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
338806666
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055060110376ColonPRO™ 4.04.0.1-SCPRO401S-US2025-04-01
78055060110375ColonPRO™ 4.04.0.1-SCPRO401S-US2025-04-01
78055060110344ColonPRO™ 4.04.0.1CPRO401-US2024-10-14
08055060110338GI Genius™ Module 300GGM300-US2024-09-22
08055060110291ColonPRO™ 4.0CPRO40.US2024-02-26
78055060110290ColonPRO™ 4.0CPRO40.US2024-02-26
08055060110314GI Genius™ Module 100GGM100.US2024-02-26
08055060110321GI Genius™ Module 200GGM200.US2024-02-26
08055060110178USB K-switchAccessory to GI GeniusUKS012023-08-11
08055060110185FootswitchAccessory to GI GeniusFS012023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065010840065CADDIEODIN MEDICAL LIMITEDQNP2025-10-16
07290020140012MAGENTIQ-COLO (ME-APDS)MAGENTIQ EYE LTDQNP2025-08-21
08055060110376ColonPRO™ 4.0LINKVERSE SRLQNP2025-04-01
78055060110375ColonPRO™ 4.0LINKVERSE SRLQNP2025-04-01
78055060110344ColonPRO™ 4.0LINKVERSE SRLQNP2024-10-14
00860010168417SKOUT systemIterative Scopes, Inc.QNP2024-10-10
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