FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications

CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B440HVCP020PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
650-800-7937support@heartvista.com

Regulatory Flags

DUNS number
602748373
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B440HVCP030HeartVista Cardiac Package030004HVCP2022-06-01

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