Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

PCS · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1001

Classification

FDA Product Code: PCS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.1001
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown