EndoNaut System MHS
EndoNaut System MHS is an image fusion and navigation system that assists physicians in positioning surgical instruments and endovascular devices during fluoroscopy-guided procedures. It…
EndoNaut System MHS is an image fusion and navigation system that assists physicians in positioning surgical instruments and endovascular devices during fluoroscopy-guided procedures. It supports procedures in the chest, abdomen, pelvis, neck and lower limbs, including aneurysm repair, embolization and treatment of peripheral artery disease.
The system combines EndoNaut software with supporting workstation hardware. It can overlay preoperative three-dimensional vessel information on procedural fluoroscopy, or combine angiographic and fluoroscopic images. Image registration aligns the views, with user validation of the alignment.
Listed Item
“EndoNaut (System) MHS” MHS standing for “Mobile Hybrid Room” which corresponds to a combination of EndoNaut (Standalone) SW, EndoNaut Workstation, and some other “on-the-shelf” materials (deported Touch screen, WIFI transmitter/receiver. Note: The version mentionned above is the Software version of the main medical software which bears the medical features, EndoNaut (Standalone) SW. The material part being an accessory to the main medical software.
Anatomy Verification
Before deploying an invasive medical device, the physician must check the current anatomy using suitable imaging, such as contrast-enhanced angiography. The navigation information supports the surgeon’s judgment and analysis of the patient’s condition.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Therenva, France |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Manufacturer |
| 510(k) | K222070 |
| Record published | 2026-05-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222070 | 2022-10-25 |
| K212383 | 2021-08-31 |
| K171829 | 2017-09-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.