FDA.reportPublic FDA data

HeartVista Cardiac Package

Primary DI
B440HVCP030
Brand
HeartVista Cardiac Package
Company
Heartvista, Inc.
Model
030004
Catalog number
HVCP
Device description
HeartVista Cardiac Package
Published
2022-06-01
Public version status
Update
Distribution status
Not 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
B440HVCP030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
MRI system operator consoleThe primary control panel for a magnetic resonance imaging (MRI) system. Depending on the device configuration, it typically includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It is a component of a diagnostic MRI system and typically includes the capabilities to be interfaced with a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It differs from the workstation by only containing the primary controls for the direct operation of the MRI system. It is located in the direct proximity of the MRI either freestanding or integrated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602748373
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B440HVCP020HeartVista Cardiac Package020301HVCP2016-10-16

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Primary DI, Brand, Company table
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08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
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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
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