Autofuse

GUDID 00860012197200

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.

Pymedix Inc

Radiology DICOM image processing application software

• Primary Device ID: 00860012197200
• NIH Device Record Key: b8ded07d-d716-407c-ac1d-52408b3e515d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autofuse
• Version Model Number: 1
• Company DUNS: 116837202
• Company Name: Pymedix Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com
• Phone: 5136935845
• Email: customer.service@pymedix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012197200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233572

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-19
• Device Publish Date: 2024-11-11