The following data is part of a premarket notification filed by Resonance Health Analysis Services Pty Ltd with the FDA for Ferrismart Analysis System.
| Device ID | K182218 |
| 510k Number | K182218 |
| Device Name: | FerriSmart Analysis System |
| Classification | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| Applicant | Resonance Health Analysis Services Pty Ltd 141 Burswood Road Burswood, AU 6100 |
| Contact | Celine Royet |
| Correspondent | Celine Royet Emergo Global Representation LLC 141 Burswood Rd, Burswood 6100 - Australia Perth, AU |
| Product Code | PCS |
| CFR Regulation Number | 892.1001 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2018-11-30 |
| Summary: | summary |