510(k) clearances

CAD - Lower GI (EC07-01)

Xiamen Inno Medical Technology Co., Ltd. · Gastroenterology, Urology

K252853Substantially EquivalentTraditionalQNP
Open FDA's page for this record
Third party flag
N
City
Xiamen
Advisory committee description
Gastroenterology, Urology
Address 1
Unit 203-2, # 55, Chengyi N. St.
Address 2
Phase 3 Of Software Park
Statement or summary
Summary
Product code
QNP
Zip code
361024
Applicant
Xiamen Inno Medical Technology Co., Ltd.
Decision date
2026-08-05
Decision code
SESE
Country code
CN
Device name
CAD - Lower GI (EC07-01)
Advisory committee
GU
Contact
Jianqing Zhao
K number
K252853
Date received
2025-09-08
Review advisory committee
GU
Postal code
361024
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Gastrointesinal Lesion Software Detection System
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1520
Device class
2
Registration number
8010047, 3016432796, 3030626336, 3003775006, 3018901422, 3016591389, 3002808148, 3031983124, 9610877, 3001722928, 3042225166, 3018899987, 3011050570
FEI number
3016432796, 3030626336, 3003775006, 3018901422, 3016591389, 3002808148, 3031983124, 3001722928, 3002807795, 3042225166, 3018899987, 3011050570, 3008185830
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.