FDA.reportPublic FDA data

510(k) K252853

Device
CAD - Lower GI (EC07-01)
Applicant
Xiamen Inno Medical Technology Co., Ltd.
510(k) number
K252853
Product code
QNP
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-05
Date received
2025-09-08
Regulation
876.1520
Classification name
Gastrointesinal Lesion Software Detection System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jianqing Zhao
Address
Unit 203-2, # 55, Chengyi N. St. Phase 3 Of Software Park Xiamen CN 361024 361024

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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