FDA.reportPublic FDA data

HeartVista Cardiac Package

Primary DI
B440HVCP020
Brand
HeartVista Cardiac Package
Company
Heartvista, Inc.
Model
020301
Catalog number
HVCP
Device description
HeartVista Cardiac Package
Published
2016-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
B440HVCP020PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
650-800-7937support@heartvista.com

Regulatory Flags#

DUNS number
602748373
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B440HVCP030HeartVista Cardiac Package030004HVCP2022-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
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04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
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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10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
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10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
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09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19