FDA.reportPublic FDA data

ColonPRO™ 4.0

Primary DI
78055060110344
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
338806666
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08055060110345ColonPRO™ 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
08055060110345ColonPRO™ 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