Neowise

Neowise is medical imaging software for dental and medical applications that displays and visualizes 2D and 3D image files from devices such as projection radiography and CBCT. It enables radiologists, clinicians, and qualified healthcare professionals to retrieve, process, render, diagnose, review, store, print, and distribute images of adults and pediatric patients. The software also simulates treatment options and monitors mandibular jaw position relative to maxilla.

Neowise accepts 2D, 3D, optical impressions, and 3D face photos with DICOM image data volumes as input. It offers image processing capabilities including brightness/contrast adjustment, cropping, annotations, and measurements. The software stores data locally in a database and exports 2D and 3D images with related reporting. It supports TWAIN-compatible devices and can forward images to third-party software. It runs on a standard Windows PC workstation.

IEC 62304 (medical device software lifecycle processes), FDA Guidance on Medical Device Software, and ISO 14971 (risk management). The device is designed and manufactured under 21 CFR §820 and ISO 13485:2016 Quality Management System Standards.

Neowise is substantially equivalent to the predicate device Planmeca Romexis based on similarities in intended use (dental and medical image display, visualization, processing, and analysis), principle of operation, functional design, and established medical use. Both are Class II picture archiving and communications systems under 21 CFR 892.2050 with product code LLZ. Minor differences in features do not affect substantial equivalence.