FDA.reportPublic FDA data

UniSyn

Primary DI
B843UNISYN7410
Brand
UniSyn
Company
Convergent Imaging Solutions Incorporated
Model
7-4-1-PX
Device description
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. For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Published
2025-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B843UNISYN7410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Contacts#

Phone, Email table
PhoneEmail
613-212-0063support@convergentimaging.com

Regulatory Flags#

DUNS number
242364082
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B843UNISYN7520UniSyn7-5-2-PX2026-06-15
B843UNISYN7340UniSyn7-3-4-PX2025-05-02
B843UNISYN7330UniSyn7-3-3-PX2025-03-31
B843UNISYN7320UniSyn7-3-2-PX2025-01-20
B843UNISYN7510UniSyn7-5-1-PX2025-08-20
B843UNISYN531P20UniSyn5-3-1-P22020-10-05
B843UNISYN5410UniSyn5-4-1-PX2020-11-09
B843UNISYN6220UniSyn6-2-2-PX2023-01-11
B843UNISYN6230UniSyn6-2-3-PX2023-01-30
B843UNISYN6260UniSyn6-2-6-PX2025-02-10
B843UNISYN7310UniSyn7-3-1-PX2024-10-25
B843UNISYN6250UniSyn6-2-5-PX2024-08-21
B843UNISYN7210UniSyn7-2-1-PX2024-03-27
B843UNISYN7110UniSyn7-1-1-PX2023-11-10
B843UNISYN6240UniSyn6-2-4-PX2023-04-03
B843UNISYN6210UniSyn6-2-1-PX2022-11-07
B843UNISYN6110UniSyn6-1-1-PX2022-05-17
B843UNISYN5610UniSyn5-6-1-PX2022-04-13
B843UNISYN5520UniSyn5-5-2-PX2021-10-06
B843UNISYN5510UniSyn5-5-1-PX2021-06-08

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