FerriSmart

Primary DI
09369998038619
Brand
FerriSmart
Company
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
Model
v01
Device description
FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.FerriSmart is indicated to: • measure liver iron concentration in individuals with confirmed or suspected systemic iron overload • monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
Published
2024-06-07
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
PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCSLiver Iron Concentration Imaging Companion Diagnostic For DeferasiroxRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182218000FerriSmart Analysis SystemResonance Health Analysis Services Pty, Ltd.2018-11-30PCS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09369998038619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09369998038619093699980386199369998038619

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
740449913
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
09355529000026FerriScan Phantomv1.0 (15 vials (0 to 3.2 mM))2016-11-10
09355529000002FerriScan, Cardiac T2*4.0.02023-06-19
09355529000040HepaFat-ScanV1.1.02023-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09355529000057FerriSmartRESONANCE HEALTH ANALYSIS SERVICES PTY LTDPCS2024-06-06
09355529000026FerriScan PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDPCS2016-11-10