EW10-EC02 Endoscopy Support Program
FDA 510(k) K230751 · Fujifilm Corporation
510(k) numberK230751
Submission
- Device name
- EW10-EC02 Endoscopy Support Program
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- March 17, 2023
- Decision date
- December 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNP – Gastrointesinal Lesion Software Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1520
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code QNP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260133 | CaddieQNP · Special | Odin Medical Limited | 09/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | Fujifilm Corporation | 08/07/2026SE |
| K252853 | CAD - Lower GI (EC07-01)QNP · Traditional | Xiamen Inno Medical Technology Co., Ltd. | 08/05/2026SE |
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 05/29/2026SE |
| K260724 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 04/03/2026SE |
| K253664 | SKOUT systemQNP · Special | Iterative Health | 12/22/2025SE |
| K252178 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 10/03/2025SE |
| K252586 | CaddieQNP · Special | Odin Medical Limited | 09/12/2025SE |
| K251126 | SKOUT systemQNP · Special | Iterative Health | 05/09/2025SE |
| K244023 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 01/24/2025SE |
More from Magentiq Eye, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | 09/04/2026SE |
| K261170 | BA-004CCITX · Traditional | 08/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | 08/07/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | 07/02/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | 06/16/2026SE |
| K254075 | Synapse Lung Nodule AIOEB · Traditional | 05/27/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | 04/30/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | 04/06/2026SE |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | 03/09/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | 02/17/2026SE |
Questions and answers
When was EW10-EC02 Endoscopy Support Program cleared by the FDA?
EW10-EC02 Endoscopy Support Program (K230751) received a 510(k) decision of Substantially Equivalent on December 15, 2023, 273 days after the submission was received.
What is the product code of K230751?
The FDA product code is QNP – Gastrointesinal Lesion Software Detection System, a Class II (moderate risk) device regulated under 21 CFR 876.1520.