Device
“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” ma...
Manufacturer
THERENVA
THERENVA
Model: 1.2
DI: 03760262480084
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
“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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4c6cb7bb-a28e-4b0c-b863-d1b7e9afa040
Distribution Status:
In Commercial Distribution
DUNS Number:
296780716
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
03760262480084
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61496
Name: Surgical planning/navigation-enhancement system
Definition:
A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.
FDA Product Codes
OWB
Interventional Fluoroscopic X-Ray System
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K222070
Supplement Number:
000