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510(k) Data Aggregation
K Number
K241508Device Name
SKOUT® system
Manufacturer
Iterative Scopes, Inc.
Date Cleared
2024-07-03
(36 days)
Product Code
QNP
Regulation Number
876.1520Why did this record match?
Applicant Name (Manufacturer) :
Iterative Scopes, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.
Device Description
The SKOUT system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.
Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal.
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K Number
K240781Device Name
SKOUT® system
Manufacturer
Iterative Scopes, Inc.
Date Cleared
2024-04-19
(29 days)
Product Code
QNP, ONP
Regulation Number
876.1520Why did this record match?
Applicant Name (Manufacturer) :
Iterative Scopes, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.
Device Description
The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.
Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal.
Ask a Question
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