Resonance Health Analysis Services Pty, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Resonance Health Analysis Services Pty, Ltd.” (first 2011, latest 2023), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 97 days. Since 2017 the median was 70 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 520 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 107 |
| 2019 | 0 | — |
| 2020 | 1 | 231 |
| 2021 | 1 | 27 |
| 2022 | 0 | — |
| 2023 | 1 | 32 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Resonance Health Analysis Services Pty, Ltd. took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
| PCS | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | 3 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (7)
Most recent Resonance Health Analysis Services Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231459 | HepaFatSmart (V2.0.0) | LNH | 2023-06-20 | 32 |
| K213776 | LiverSmart | PCS | 2021-12-29 | 27 |
| K201039 | HepaFat-AI | LNH | 2020-12-07 | 231 |
| K182218 | FerriSmart Analysis System | PCS | 2018-11-30 | 107 |
| K122035 | HEPAFAT SCAN | LNH | 2013-12-13 | 520 |
| K111222 | MRI-Q SYSTEM | LLZ | 2011-07-28 | 87 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130012 | De Novo | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | 2013-01-23 |
Recalls
openFDA lists no recalls under a recalling firm named Resonance Health Analysis Services Pty, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Resonance Health Analysis Services Pty, Ltd. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Resonance Innovations, LLC (8 510(k)s)
- Resonance Technology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Resonance Health Analysis Services Pty, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Resonance Health Analysis Services Pty, Ltd.” (first 2011, latest 2023), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Resonance Health Analysis Services Pty, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Resonance Health Analysis Services Pty, Ltd. is 97 days. Since 2017: 70 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Resonance Health Analysis Services Pty, Ltd.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 3); PCS (Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox, 3); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 6 Resonance Health Analysis Services Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Resonance Health Analysis Services Pty, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.