Device
XENOVIEW VDP is an image analysis platform that quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompa...
Manufacturer
Polarean, Inc.
Polarean, Inc.
Model: 1.2.2
Catalog: 35790
DI: 00850045949136
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
XENOVIEW VDP is an image analysis platform that quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image. The software provides a user-friendly interface and simple workflow that helps guide the user through the image analysis process, including the loading of images, registration of the anatomical image sets to the HP 129Xe image sets, segmentation of the lung, and automated classification of normalized ventilation distribution into multiple intensity levels via analysis of hyperpolarized 129Xe signal intensity within the segmented lung volume. The results of the image analysis are output as medical images of the classified ventilation, a summary report, and data files containing quantitative statistical analysis results.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
338f4e97-1415-4920-b0ab-6730ba763df5
Distribution Status:
In Commercial Distribution
DUNS Number:
078629330
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850045949136
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66599
Name: MRI image interpretive software
Definition:
An interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K223071
Supplement Number:
000