510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252853Substantially Equivalent

CAD - Lower GI (EC07-01)

Xiamen Inno Medical Technology Co., Ltd., Xiamen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252853 is the FDA 510(k) clearance record for CAD - Lower GI (EC07-01), a class II device, cleared for Xiamen Inno Medical Technology Co., Ltd. on under FDA product code QNP (Gastrointesinal Lesion Software Detection System). FDA's definition for product code QNP reads: "A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software...". FDA records list one 510(k) clearance for Xiamen Inno Medical Technology Co., Ltd. As of , FDA records show no recalls naming K252853.

Clearance record

Decision date
Received
(331 days to decision)
Product code
QNP Gastrointesinal Lesion Software Detection System
Regulation
21 CFR 876.1520
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Xiamen Inno Medical Technology Co., Ltd. Unit 203-2, # 55, Chengyi N. St., Xiamen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNP

Trailing 12 months
6 clearances under product code QNP in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QNP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20262
September 20261
October 20260