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

Gastrointesinal Lesion Software Detection System

21 CFR 876.1520 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QNP is the FDA product code for Gastrointesinal Lesion Software Detection System, a class II device type, regulated under 21 CFR 876.1520. FDA's definition for this code 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 algorithms brings attention to images to aid in the detection of lesions. The device may...". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QNP
Device name
Gastrointesinal Lesion Software Detection System
FDA definition
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 algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
Regulation
21 CFR 876.1520
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
0

Clearances, product code QNP

By decision year
23 clearances under product code QNP with a decision year between 2021 and 2026, 2024 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code QNP by decision year
YearClearances
20213
20221
20234
20245
20255
20265

Applicants with the most clearances

Product code QNP
Applicants holding the most 510(k) clearances under product code QNP
ApplicantClearances
Cosmo Artificial Intelligence - Ai, Ltd.6
Iterative Scopes, Inc.4
Magentiq Eye Ltd4
FUJIFILM Corporation2
Iterative Health2
Odin Medical Limited2
Chengdu Wision Medical Device Co., Ltd.1
Odin Medical Limited1
Xiamen Inno Medical Technology Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order