LiverSmart
FDA 510(k) K213776 · Resonance Health Analysis Services Pty, Ltd.
Submission
- Device name
- LiverSmart
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
Perth, AU - Received
- December 2, 2021
- Decision date
- December 29, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCS – Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1001
- Specialty
- Radiology
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…
Other 510(k)s with product code PCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182218 | FerriSmart Analysis SystemPCS · Traditional | Resonance Health Analysis Services Pty, Ltd. | 11/30/2018SE |
More from Resonance Health Analysis Services Pty, Ltd.
Questions and answers
When was LiverSmart cleared by the FDA?
LiverSmart (K213776) received a 510(k) decision of Substantially Equivalent on December 29, 2021, 27 days after the submission was received.
What is the product code of K213776?
The FDA product code is PCS – Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox, a Class II (moderate risk) device regulated under 21 CFR 892.1001.