FDA Product Code
FDA Product Code PCS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1001
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213776 | LiverSmart | Resonance Health Analysis Services Pty, Ltd. | 2021-12-29 | Special | PDF ↗ |
| K182218 | FerriSmart Analysis System | Resonance Health Analysis Services Pty, Ltd. | 2018-11-30 | Traditional | PDF ↗ |
| DEN130012 | FERRISCAN R2-MRI ANALYSIS SYSTEM | Resonance Health Analysis Services Pty, Ltd. | 2013-01-23 | Direct | — |
Product code PCS · Class II · Radiology. Data: openFDA.