XENOVIEW VDP

Primary DI
00850045949136
Brand
XENOVIEW VDP
Company
Polarean, Inc.
Model
1.2.2
Catalog number
35790
Device 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.
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K223071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223071000Xenoview VDPPolarean, Inc.2022-12-23LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045949136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045949136008500459491368500459491360850045949136

GMDN Terms#

Term, Definition table
TermDefinition
MRI image interpretive softwareAn 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].

Regulatory Flags#

DUNS number
078629330
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045949075XENOVIEW 3.0T Chest Coil-GE PremierRev A44315-042025-12-19
00850045949082HPX Polarization Measurement StationRev. E428812025-10-13
00850045949099XENOVIEW Dose Delivery Bag, Carton of 50, 1,000 mLRev A47471-1002025-10-13
00850045949105XENOVIEW Dose Delivery Bag, Carton of 50, 750 mLRev A47471-0752025-10-13
00850045949112XENOVIEW Dose Delivery Bag, Carton of 50, 500 mLRev A47471-0502025-10-13
00850045949129XENOVIEW Dose Delivery Bag, Carton of 50, 300 mLRev A47471-0302025-10-13
00850045949044XENOVIEW 3.0T Chest CoilRev C44315-012025-09-23
00850045949051XENOVIEW 3.0T Chest CoilRev B44315-032025-09-23
00850045949006HPX HyperpolarizerRev E498202023-05-04
00850045949013XENOVIEW Dose Delivery BagRev B44639-012023-05-04
00850045949020HPX Polarization Measurement StationRev. D428812023-05-04
00850045949037HPX Gas Handling ManifoldRev E456602023-05-04

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