FerriScan Phantom

GUDID 09355529000026

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)

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

MRI phantom, test object

• Primary Device ID: 09355529000026
• NIH Device Record Key: c9450f85-25e6-442e-94d4-77a98e802ace
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FerriScan Phantom
• Version Model Number: v1.0 (15 vials (0 to 3.2 mM))
• Company DUNS: 740449913
• Company Name: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09355529000026 [Primary]
GS1	09369999026356 [Previous]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-04-18
• Device Publish Date: 2016-11-10

Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

• 09369998038619 - FerriSmart: 2024-06-17 FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing t
• 09355529000057 - FerriSmart: 2024-06-14 FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (L
• 09355529000095 - HepaFatSmart: 2024-05-07 Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) d
• 09355529000033 - T1CMR Phantom (1.5T): 2024-04-25 The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement i
• 09355529000064 - T1CMR Phantom (3.0T): 2024-04-25 The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement i
• 09355529000071 - T2CMR Phantom: 2024-04-25 Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of n
• 09355529000088 - R2*/T2* Phantom: 2024-04-25 The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential
• 09355529000026 - FerriScan Phantom: 2024-04-18Sealed 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)
• 09355529000026 - FerriScan Phantom: 2024-04-18 Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydr