UniSyn
GUDID B843UNISYN5520
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 | B843UNISYN5520 |
| NIH Device Record Key | 5367c207-a9c8-4b1e-9a6f-199138f90209 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UniSyn |
| Version Model Number | 5-5-2-PX |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B843UNISYN5520 [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 | 2021-10-14 |
| Device Publish Date | 2021-10-06 |
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 |
| B843UNISYN6250 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN7310 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN7320 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN6260 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN7410 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN6230 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN6220 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN5410 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN531P20 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN7330 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN7340 | UniSyn is a software application for image registration and fusion display of scanned image data |
| B843UNISYN7510 | UniSyn is a software application for image registration and fusion display of scanned image data |
Trademark Results [UniSyn]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNISYN 98120468 not registered Live/Pending |
MGX Holdings, Inc. 2023-08-08 |
 UNISYN 88675764 not registered Live/Pending |
Unisyn Insurance, Inc. 2019-10-31 |
 UNISYN 87722156 not registered Live/Pending |
ESQIDO LTD 2017-12-15 |
 UNISYN 87110939 5162968 Live/Registered |
Lytx, Inc. 2016-07-20 |
 UNISYN 87110927 5318121 Live/Registered |
Lytx, Inc. 2016-07-20 |
 UNISYN 87064103 not registered Dead/Abandoned |
Consensus Orthopedics Inc. 2016-06-08 |
 UNISYN 77858744 3951777 Dead/Cancelled |
GENERAL ELECTRIC COMPANY 2009-10-27 |
 UNISYN 77858739 3905464 Dead/Cancelled |
GENERAL ELECTRIC COMPANY 2009-10-27 |
 UNISYN 77858737 3905463 Dead/Cancelled |
GENERAL ELECTRIC COMPANY 2009-10-27 |
 UNISYN 77858733 not registered Dead/Abandoned |
UNISYN MEDICAL TECHNOLOGIES, INC. 2009-10-27 |
 UNISYN 77858731 3905462 Dead/Cancelled |
GENERAL ELECTRIC COMPANY 2009-10-27 |
 UNISYN 77858729 3905461 Dead/Cancelled |
GENERAL ELECTRIC COMPANY 2009-10-27 |
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