FDA.reportPublic FDA data

VitruvianScan

Primary DI
B554VSMD1000
Brand
VitruvianScan
Company
PERSPECTUM LTD
Model
1.0
Device description
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).
Published
2024-11-01
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
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B554VSMD1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
218593632
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B554CSMD1200CoverScan1.2.02025-02-03
B554CSMD1100CoverScan1.1.02024-11-01
B554LMS5100LiverMultiScan5.1.02024-11-01
B554MRCP2000MRCP+2.0.02024-03-28
B554CSMD1000CoverScan1.0.02022-09-14
B554LMS3500LiverMultiScan3.5.02022-09-14
B554LMS4000LiverMultiScan4.0.02022-09-14
B554LMS5000LiverMultiScan5.0.02022-09-14
B554HEPATICA100Hepatica1.0.02021-02-12
B554LMS3400LiverMultiScan3.4.02020-11-03
B554LMS3300LiverMultiScan3.3.02020-03-20
B554LMS3200LiverMultiScan3.2.02020-01-13
B554LMS3100LiverMultiScan3.1.02019-09-17
B554LMS2100LiverMultiScan2.12018-07-04
B554MRCP1000MRCP+1.02019-02-04
B554LMS2000LiverMultiScan2.02018-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
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B66910041MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
B66910051MRIaudioPREM1004MRIAUDIO, INC.LNH2026-03-31
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
00195278601162NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDLNH2025-04-15
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19
B237ZXLADK600Zephyr Patient Positioning and Transfer SystemDiacor, Inc.LNH2023-06-08
10841962119402Applicator Clamp HolderQfixLNH2023-05-05