FDA.reportPublic FDA data

FerriScan Phantom

Primary DI
09355529000026
Brand
FerriScan Phantom
Company
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Model
v1.0 (15 vials (0 to 3.2 mM))
Device description
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
Published
2016-11-10
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
PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
PCSLiver Iron Concentration Imaging Companion Diagnostic For DeferasiroxRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09369999026356PreviousGS10
09355529000026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09369999026356093699990263569369999026356
09355529000026093555290000269355529000026

GMDN Terms#

Term, Definition table
TermDefinition
MRI phantom, test objectA device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature4 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61892865300quality@resonancehealth.com

Regulatory Flags#

DUNS number
740449913
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09369998038619FerriSmartv012024-06-07
09355529000019HepaFat-AIV1.0.02024-06-07
09355529000057FerriSmartv2.2.4-2024-06-06
09355529000095HepaFatSmartv2.0.0-2024-04-29
09355529000033T1CMR Phantom (1.5T)v1.0-2024-04-17
09355529000064T1CMR Phantom (3.0T)v1.0-2024-04-17
09355529000071T2CMR Phantomv1.0-2024-04-17
09355529000088R2*/T2* Phantomv1.0-2024-04-17
09355529000002FerriScan, Cardiac T2*4.0.02023-06-19
09355529000040HepaFat-ScanV1.1.02023-06-16

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Primary DI, Brand, Company table
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08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
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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
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08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
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