FDA.reportPublic FDA data

GI Genius

Primary DI
10884521844537
Brand
GI Genius
Company
Covidien LP
Model
GGS100
Device description
GGI Genius (TM) System 100
Published
2023-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K231143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231143000GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd.2023-05-19QNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521844537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452184453710884521844537

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal101 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure75 KiloPascal101 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521833012BeaconN-19-052026-09-05
10884521833029BeaconN-22-052026-09-05
10884521833036BeaconN-25-052026-09-05
10884521833043SharkCoreDSC-22-012026-09-06
10884521833050SharkCoreDSC-25-012026-09-06
10884521833067SharkCoreC-22-052026-09-06
10884521833074SharkCoreC-25-052026-09-06
10884521833081SharkCoreDSL-19-012026-09-06
10884521833142BeaconDSN-19-012026-09-05
10884521833159BeaconDSN-22-012026-09-05
10884521833166BeaconDSN-25-012026-09-05
10884521197701superDimensionSDC102016-09-24
10884521198777superDimensionSDC202016-09-24
10884521198784superDimensionSDC52016-09-24
10884521198791superDimensionSDM22016-09-24
10884521198807superDimensionSDM32016-09-24
10884521539709SuperLockSDGN4472016-09-24
10884521757868Maxon8886621943-22020-01-29
10884521762688SuperLockSDGN4472021-07-05
10884521837102ILLUMISITEILS-1000-CS2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521855359GI GeniusCovidien LPQNP2026-07-26
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
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
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