Device
Medit AuraVue is a software application intended to support patient consultation and clinical communication by displaying dental imaging data (intraoral Scan data and panoramic ima...
Manufacturer
Medit Corp.
Medit Corp.
Model: MA-AAV
DI: 08800026700890
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Distribution End: 2026-05-14
Description
Medit AuraVue is a software application intended to support patient consultation and clinical communication by displaying dental imaging data (intraoral Scan data and panoramic image data) and diagnostic results processed by third-party AI software, and generating reports. Medit AuraVue is intended for viewing and communication purposes only and does not provide independent diagnostic analysis or treatment recommendations.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b9e2cf41-c4d4-496f-aeee-04bb03e29d20
Distribution Status:
Not in Commercial Distribution
DUNS Number:
688800085
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08800026700890
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60723
Name: Medical image management system
Definition:
A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].
FDA Product Codes
LMD
System, Digital Image Communications, Radiological