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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointesinal Lesion Software Detection System
510(k) Number K252853
Device Name CAD - Lower GI (EC07-01)
Applicant
Xiamen Inno Medical Technology Co., Ltd.
Unit 203-2, # 55, Chengyi N. St.
Phase 3 Of Software Park
Xiamen,  CN 361024
Applicant Contact Jianqing Zhao
Correspondent
Zhihe Info-Tech(Suzhou) Co., Ltd.
Rm. 616, Bldg. 1, # 1 Huayun Rd., Industrial Park
Suzhou,  CN 215134
Correspondent Contact Rachel Yu
Regulation Number876.1520
Classification Product Code
QNP  
Date Received09/08/2025
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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