Visible Patient Suite

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K151988

by Visible Patient, Sas

Identity

Trade Name: Visible Patient Suite FDA UDI
Generic Name: Radiology picture archiving and communication system digital archive device FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 1.0.11 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: B373VPS10110 FDA UDI
510(k) Number: K151988 FDA 510(k)FDA UDI
FDA Product Code: LLZ FDA 510(k)FDA UDI
GMDN Term: Radiology picture archiving and communication system digital archive device FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 892.2050 FDA 510(k)
Regulation Number: 892.2050 FDA 510(k)FDA UDI
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Visible Patient Suite by Visible Patient, Sas — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K151988	Class II	Active

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Manufacturer

Manufacturer: Visible Patient, Sas

Sources (2)

FDA 510(k) K151988 24 fields · synced Jun 18, 2026
FDA UDI a281c248-666a-48af-ad84-334a206b2376 34 fields · synced May 26, 2026