Device
Neowise is a medical imaging software intended for use in dental and medical applications as a tool for displaying and visualizing dental and medical 2D and 3D image files from ima...
Manufacturer
CEFLA SOCIETA' COOPERATIVA
CEFLA SOCIETA' COOPERATIVA
Model: Neowise
Catalog: 7XPD
DI: 08033837938835
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
Description
Neowise is a medical imaging software intended for use in dental and medical applications as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
42786e8c-b50d-40c5-84be-c8e5d10c22f6
Distribution Status:
In Commercial Distribution
DUNS Number:
429341410
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08033837938835
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65472
Name: Dental x-ray image interpretive software
Definition:
An interpretive software program intended to be used to analyse dental x-ray images (e.g., panoramic and bitewing) to facilitate the localization and classification of teeth, detect abnormalities (e.g., caries, apical lesion), and identify past dental procedures (e.g., fillings, crowns, bridges, implants); it utilizes artificial intelligence (AI)/deep learning algorithms.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K260716
Supplement Number:
000