FDA product code PCS: Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
PCS is the FDA product code for liver iron concentration imaging companion diagnostic for deferasirox. It is a Class II device, regulated under 21 CFR 892.1001 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under PCS. The average 510(k) review took 67 days (median 67). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Device class | Class II |
| Regulation | 21 CFR 892.1001 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for PCS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 107 |
| 2021 | 1 | 27 |
Compare with all 510(k) review times · Search every PCS clearance
Top PCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Resonance Health Analysis Services Pty, Ltd. | 2 | 2021-12-29 |
Most recent PCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213776 | Resonance Health Analysis Services Pty, Ltd. | LiverSmart | 2021-12-29 | 27 |
| K182218 | Resonance Health Analysis Services Pty, Ltd. | FerriSmart Analysis System | 2018-11-30 | 107 |
Recalls for PCS devices
openFDA lists no recalls for product code PCS.
Frequently asked questions
What is FDA product code PCS?
PCS is the FDA product code for liver iron concentration imaging companion diagnostic for deferasirox. It is a Class II device, regulated under 21 CFR 892.1001 and reviewed by the Radiology panel.
What device class is PCS?
Class II, regulation 21 CFR 892.1001. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCS?
Across 2 cleared submissions the average was 67 days from receipt to decision (median 67).
Which companies have the most PCS clearances?
Resonance Health Analysis Services Pty, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PCS
- Run a recall and safety report across every PCS manufacturer
- Watch product code PCS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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