FDA Product Code PCS: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Intended For Diagnostic Use To Present Images That Reflect The Magnetic Resonance Spectra For The Determination Of Iron In The Liver For Any Indication Where An Assessment Of Liver Iron Concentration Is Needed. For Non-transfusion-dependent Thalassemia (ntdt) Patients, Is Intended As An Aid In The Assessment Of Ntdt Patients For Whom Deferasirox Therapy Is Being Considered And For Monitoring Of Ntdt Patients Receiving Deferasirox Therapy.
Leading manufacturers include Resonance Health Analysis Services Pty, Ltd..
FDA 510(k) Cleared Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox Devices (Product Code PCS)
About Product Code PCS - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PCS since 2013, with 2 receiving FDA clearance (average review time: 52 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
PCS devices are reviewed by the Radiology panel. Browse all Radiology devices →