K182218 is an FDA 510(k) clearance for the FerriSmart Analysis System. This device is classified as a Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox (Class II - Special Controls, product code PCS).
Submitted by Resonance Health Analysis Services Pty, Ltd. (Perth, AU). The FDA issued a Cleared decision on November 30, 2018, 107 days after receiving the submission on August 15, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1001. 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..
| 510(k) Number | K182218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2018 |
| Decision Date | November 30, 2018 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PCS - Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1001 |
| Definition | 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. |