FDA.reportPublic FDA data

Visible Patient Suite

Primary DI
B373VPS10150
Brand
Visible Patient Suite
Company
VISIBLE PATIENT
Model
1.0.15
Device description
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.
Published
2020-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151988000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151988000Visible Patient SuiteVisible Patient, Sas2015-10-15LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B373VPS10150PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
265312689
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770029173050Visible Patient Suite1.0.222026-04-17
VPS1019Visible Patient Suite1.0.192023-12-21
B373VPS0Visible Patient Suite1.0.182023-01-27
B373VPS10170Visible Patient Suite1.0.172022-07-22
B373VPS10130Visible Patient Suite1.0.132021-07-15
B373VPS10140Visible Patient Suite1.0.142021-07-15
B373VPS10120Visible Patient Suite1.0.122019-08-16
B373VPS10100Visible Patient Suite1.0.102017-02-01
B373VPS10110Visible Patient Suite1.0.112017-12-04
B373VPS1090Visible Patient Suite1.0.92016-09-24

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