FDA.reportPublic FDA data

GI Genius™ Module 300

Primary DI
08055060110338
Brand
GI Genius™ Module 300
Company
LINKVERSE SRL
Model
GGM300-US
Device description
GI Genius™ system with software ColonPRO™.
Published
2024-09-22
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
08055060110338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055060110338080550601103388055060110338

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image interpretive unitAn electrically-powered computing unit intended to analyse endoscopic video images to automatically detect and localize suspected abnormalities and lesions (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and display monitor, and will typically use artificial intelligence (AI)/deep learning software to identify abnormalities and overlay visual flags/markers on video images to highlight regions of interest to clinicians.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75.3 KiloPascal101.3 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure75.3 KiloPascal101.3 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
338806666
Device count
1
Serial number
true
Manufacturing date on label
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
08055060110345ColonPRO™ 4.04.0.1CPRO401-US2024-10-14
78055060110344ColonPRO™ 4.04.0.1CPRO401-US2024-10-14
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
78055060110344ColonPRO™ 4.0LINKVERSE SRLQNP2024-10-14
00860010168417SKOUT systemIterative Scopes, Inc.QNP2024-10-10
15065010840024CADDIEODIN MEDICAL LIMITEDQNP2024-10-01
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