FerriScan Phantom

FDA UDI

Class II (US FDA UDI)

by Resonance Health Analysis Services Pty, Ltd.

Identity

Trade Name: FerriScan Phantom FDA UDI
Generic Name: MRI phantom, test object FDA UDI
Device Name: 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) FDA UDI
Model / Reference: v1.0 (15 vials (0 to 3.2 mM)) FDA UDI
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) FDA UDI

Identifiers

Primary DI / UDI-DI: 09355529000026 FDA UDI
FDA Product Code: LNH FDA UDI
PCS FDA UDI
GMDN Term: MRI phantom, test object FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
892.1001 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: MRI phantom, test object

FerriScan Phantom by Resonance Health Analysis Services Pty, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Resonance Health Analysis Services Pty, Ltd.

Sources (1)

FDA UDI c9450f85-25e6-442e-94d4-77a98e802ace 35 fields · synced Jun 8, 2026