FerriSmart

Organization name

Resonance Health Analysis Services

SRN

AU-MF-000026337

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  Please download eIFU from https://secure.ferriscan.com/ or email us at support@resonancehealth.com

• Caution

  STOP the FerriSmart MRI acquisition if CONTRAST AGENT has been given to the patient in the last 7 days including this session.

• Ensure the MAJORITY OF THE LIVER is at the LEFT-HAND SIDE OF THE IMAGE FOV regardless the anatomical liver location or scanning arrangement. Otherwise, the analysis result could be incorrect.

  OTHER

• Ensure SEVERE motion artefacts are absent in the liver region for all the five TE images (shown in the report) from the selected slice. Otherwise, the analysis result could be impacted with increased uncertainty.

  OTHER

• Ensure no EXCESSIVE EMPTY SPACE is within the FOV of the selected slice (shown in the report), especially for a patient with a small body size. Otherwise, the analysis result could be impacted with increased uncertainty.

  OTHER

• Ensure CONSISTENT parameter settings, patient position and hardware condition (coil consistency) are used for ALL five TEs of the FerriSmart data. Otherwise, the analysis result could be impacted with increased uncertainty.

  OTHER

Primary placement in Austria; available across 12 countries total.

Trade name

FerriSmart

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

93555290000570

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

93555290FSM44

Reference / catalog number

Version 2.2.4

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (LIC) from MRI images for the full spectrum of R2 and LIC known clinically.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.