27 devices · 18 companies · 2018 to 2026
AI-enabled gastroenterology-urology devices on FDA's list
27 devices in the Gastroenterology-Urology panel, 2018 to 2026, from 18 companies across 6 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (27 of 27 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Gastroenterology-Urology panel
- QNP · Gastrointesinal Lesion Software Detection System20
- SFE · Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation2
- QZF · Gastrointestinal Capsule Endoscopy Analysis Software Device2
- MYE · System, Electrogastrography (Egg)1
- QZB · Software Controlled Endoscope And Instrument Holder1
- NAY · System, Surgical, Computer Controlled Instrument1
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Instrument Exit Point on Touch Surgery AideK253984 · 510(k) | Covidien, LLC | SFE | database entry | |
| GI Genius Module 300K261369 · 510(k) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | database entry | |
| MAGENTIQ-COLOK260724 · 510(k) | Magentiq Eye, Ltd. | QNP | database entry | |
| Deep CapsuleK250655 · 510(k) | Digestaid - Artificial Intelligence Development SA | QZF | database entry | |
| SKOUT systemK253664 · 510(k) | Iterative Health | QNP | database entry | |
| Gastric AlimetryK252504 · 510(k) | Alimetry , Ltd. | MYE | database entry | |
| MAGENTIQ-COLOK252178 · 510(k) | Magentiq Eye, Ltd. | QNP | database entry | |
| CADDIEK252586 · 510(k) | Odin Medical Limited | QNP | database entry | |
| Maestro SystemK250984 · 510(k) | Moon Surgical | QZB | database entry | |
| HyperSnap Surgical SystemK250268 · 510(k) | Hypervision Surgical | SFE | database entry | |
| SKOUT systemK251126 · 510(k) | Iterative Health | QNP | database entry | |
| MAGENTIQ-COLOK244023 · 510(k) | Magentiq Eye LTD | QNP | database entry | |
| GI Genius Module 100K241887 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | QNP | database entry | |
| CADDIEK240044 · 510(k) | Odin Medical Limited | QNP | database entry | |
| SKOUT systemK241508 · 510(k) | Iterative Scopes, Inc. | QNP | database entry | |
| SKOUT systemK240781 · 510(k) | Iterative Scopes, Inc. | QNP | database entry | |
| GI Genius Module 100K233964 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | QNP | database entry | |
| EW10-EC02 Endoscopy Support ProgramK230751 · 510(k) | FUJIFILM Corporation | QNP | database entry | |
| NaviCam ProScanDEN230027 · De Novo | Ankon Technologies co., ltd | QZF | database entry | |
| ME-APDSK223473 · 510(k) | Magentiq Eye LTD | QNP | database entry | |
| GI Genius System 100 and GI Genius System 200K231143 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | QNP | database entry | |
| SKOUT systemK230658 · 510(k) | Iterative Scopes Inc. | QNP | database entry | |
| SKOUT SoftwareK213686 · 510(k) | Iterative Scopes Inc. | QNP | database entry | |
| EndoScreenerK211326 · 510(k) | Chengdu Wision Medical Device Co., LTD. | QNP | database entry | |
| GI GeniusK211951 · 510(k) | Cosmo Artificial Intelligence - AI Ltd | QNP | database entry | |
| GI GeniusDEN200055 · De Novo | Cosmo Artificial Intelligence - AI, LTD | QNP | database entry | |
| TransEnterix Senhance Surgical SystemK180163 · 510(k) | TransEnterix, Inc. | NAY | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.