VitruvianScan

GUDID B554VSMD1000

VitruvianScan is a standalone, post processing software as a medical device (SaMD). VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit).

PERSPECTUM LTD

Radiology DICOM image processing application software

• Primary Device ID: B554VSMD1000
• NIH Device Record Key: 1eb3eb71-b9ef-4f64-ab2a-1938a882cfe6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitruvianScan
• Version Model Number: 1.0
• Company DUNS: 218593632
• Company Name: PERSPECTUM LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B554VSMD1000 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by PERSPECTUM LTD

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• B554CSMD1100 - CoverScan: 2024-11-11 CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of
• B554LMS5100 - LiverMultiScan: 2024-11-11 LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive l
• B554VSMD1000 - VitruvianScan: 2024-11-11VitruvianScan is a standalone, post processing software as a medical device (SaMD). VitruvianScan enables the generation, display and review of magnetic resonance (MR) medical image data from a single timepoint (one patient visit).
• B554VSMD1000 - VitruvianScan: 2024-11-11 VitruvianScan is a standalone, post processing software as a medical device (SaMD). VitruvianScan enables the generation, displa
• B554MRCP2000 - MRCP+: 2024-04-05 MRCP+ v2 is a standalone software medical device. The purpose of the MRCP+ v2 device is to assist a trained operator with the qu
• B554CSMD1000 - CoverScan: 2022-09-22 CoverScan is a medical image management and processing software package that allows the display, analysis and post-processing of
• B554LMS3500 - LiverMultiScan: 2022-09-22 LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live
• B554LMS4000 - LiverMultiScan: 2022-09-22 LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive live