EndoScreener

Primary DI
06973770840012
Brand
EndoScreener
Company
Chengdu Wision Medical Device Co., Ltd.
Model
WIPD01
Published
2022-04-26
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
K211326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211326000EndoScreenerChengdu Wision Medical Device Co., Ltd.2021-11-19QNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973770840012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973770840012069737708400126973770840012

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; it may in addition be intended to differentiate lesions (e.g., neoplastic versus non-neoplastic). It is intended to be installed on an off-the-shelf desktop or laptop computer, 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

Contacts#

Phone, Email table
PhoneEmail
+1 857 268 9686support@wision.com

Regulatory Flags#

DUNS number
409737912
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
10884521821545GI GeniusCovidien LPQNP2021-11-20
10884521807259GI GeniusCovidien LPQNP2021-04-30