DEVICE: Visible Patient Suite (B373VPS10130)
Device Identifier (DI) Information
Visible Patient Suite
1.0.13
In Commercial Distribution
VISIBLE PATIENT
1.0.13
In Commercial Distribution
VISIBLE PATIENT
Visible Patient Suite is medical imaging software that is intended to provide trained medical
professionals with tools to aid them in reading, interpreting, reporting, and treatment planning.
Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
The software provides several categories of tools. It includes basic imaging tools for general images
, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR),
image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.
It includes a basic image processing workflow and a custom UI to segment anatomical structures,
which are visible in the image data (bones, organs, vascular/airway structures, etc.), including
interactive segmentation tools, basic image filters, etc.
It also includes detection and labeling tools of organ segments (liver, lungs and kidneys),
including path definition through vascular/airway, approximation of vascular/airway territories
from tubular structures and interactive labeling.
The software is designed to be used by trained professionals (including physicians,
surgeons and technicians) and is intended to assist the clinician who is solely responsible
for making all final patient management decisions.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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41669 | Radiology picture archiving and communication system digital archive device |
A mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K151988 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
a6e2c7d7-022f-4058-a9d1-7b31f1d3faaf
July 23, 2021
1
July 15, 2021
July 23, 2021
1
July 15, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined