Promaxo MRI System

Primary DI
00860006901127
Brand
Promaxo MRI System
Company
Promaxo, Inc.
Model
PR071-001-R
Catalog number
PR071-001-R
Device description
Magnetic Resonance Imaging System, Auxiliary Rack
Published
2022-04-19
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
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006901127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006901127008600069011278600069011270860006901127

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, permanent magnetA general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other patient accessible designs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103665187
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042098165Template Holder with Fiducials19610196102026-01-21
00850042098080MRI Large RX Coil (Receive Only)6761-L 6761-L2022-08-31
00850042098103Template Arm17279172792022-08-31
00850042098042Fiducial Coil with Arm Mount (Receive Only)718171812022-08-30
00850042098028MRI Large Receive Coil6761-L6761-L2022-06-27
00850042098035MRI Medium Receive Coil6761-M6761-M2022-06-27
00850042098097MRI Medium RX Coil (Receive Only)6761-M6761-M2022-08-31
00860006901110Promaxo MRI SystemPR071-001-M PR071-001-M2022-04-19

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