FDA.reportPublic FDA data

510(k) K253664

Device
SKOUT system
Applicant
Iterative Health
510(k) number
K253664
Product code
QNP
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-22
Date received
2025-11-20
Regulation
876.1520
Classification name
Gastrointesinal Lesion Software Detection System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Caitlyn Seidl
Address
14 Arrow St., Floor 3 Cambridge MA US 02138 02138

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.2026-04-03
K252178MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.2025-10-03
K252586CADDIEOdin Medical Limited2025-09-12
K251126SKOUT systemIterative Health2025-05-09
K244023MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.2025-01-24
K241887GI 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.2024-07-25
K240044CADDIEOdin Medical Limited2024-07-24
K241508SKOUT® systemIterative Scopes, Inc.2024-07-03
K240781SKOUT® systemIterative Scopes, Inc.2024-04-19
K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)Cosmo Artificial Intelligence - Ai, Ltd.2024-01-12
K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation2023-12-15
K223473ME-APDS™; MAGENTIQ-COLO™Magentiq Eye, Ltd.2023-07-25
K231143GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd.2023-05-19
K230658SKOUT® systemIterative Scopes, Inc.2023-04-07
K213686SKOUT SoftwareIterative Scopes, Inc.2022-08-12