Resonance Health Analysis Services Pty Ltd
Burswood Western Australia, AU
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD appears in FDA device records in Burswood Western Australia, AU. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Resonance Health Analysis Services Pty Ltd between 2011 and 2023. The busiest year on record is 2013, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231459 | HepaFatSmart (V2.0.0) | LNH | Substantially Equivalent | |
| K213776 | LiverSmart | PCS | Substantially Equivalent | |
| K201039 | HepaFat-AI | LNH | Substantially Equivalent | |
| K182218 | FerriSmart Analysis System | PCS | Substantially Equivalent | |
| K122035 | HEPAFAT SCAN | LNH | Substantially Equivalent | |
| DEN130012 | FERRISCAN R2-MRI ANALYSIS SYSTEM | PCS | Unknown | |
| K111222 | MRI-Q SYSTEM | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005450718 | 3005450718 | RESONANCE HEALTH ANALYSIS SERVICES PTY LTD | 141 Burswood Road, Burswood Western Australia 6100 AU | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain