UniSyn

GUDID B843UNISYN425P20

UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

Convergent Imaging Solutions Incorporated

Radiology picture archiving and communication system workstation

• Primary Device ID: B843UNISYN425P20
• NIH Device Record Key: 72e5f175-6a4f-46bf-982c-a61cb017ebf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSyn
• Version Model Number: 4-2-5-P2
• Company DUNS: 242364082
• Company Name: Convergent Imaging Solutions Incorporated
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 613 212 0063
• Email: support@convergentimaging.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B843UNISYN425P20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081987

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: 2020-02-20
• Device Publish Date: 2020-02-12

On-Brand Devices [UniSyn]

• B843UNISYN431P10: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN425P20: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN5510: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN5520: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN5610: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN6110: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN6210: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN6240: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN7110: UniSyn is a software application for image registration and fusion display of scanned image data
• B843UNISYN7210: UniSyn is a software application for image registration and fusion display of scanned image data