Search Results
Found 1 results
510(k) Data Aggregation
K Number
K233572Device Name
Autofuse
Manufacturer
Date Cleared
2024-03-06
(121 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Pymedix
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Autofuse is a software package that provides physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume operation, volume rendering, registration and fusion of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, and other medical specialties. Autofuse is not intended for mammography.
Device Description
Autofuse is a software application providing relevant tools for Radiotherapy professionals to use while creating treatment plans.
The Autofuse device is a Picture Archiving and Communication System (medical imaging software). Autofuse provides medical image processing designed to facilitate the oncology or other clinical specialty workflow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET, CT, RT Dose and MR; draw Regions of Interest (ROI); and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, and dose.
Autofuse is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
Ask a Question
Ask a specific question about this device
Page 1 of 1