AccessGUDID - DEVICE: UniSyn (B843UNISYN7410)

GUDID

Device Identifier (DI) Information

Brand Name: UniSyn
Version or Model: 7-4-1-PX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Convergent Imaging Solutions Incorporated

Primary DI Number: B843UNISYN7410
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 242364082 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40943	Radiology picture archiving and communication system workstation	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7b2d218-d1ff-4f1e-8454-e043c09999ef
Public Version Date: February 28, 2025
Public Version Number: 1
DI Record Publish Date: February 20, 2025