Resonance Innovations, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Resonance Innovations, LLC” (first 2006, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 days. 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 | 87 |
| 2014 | 5 | 32 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 8 | 8 |
Review panels
- Radiology (8)
Most recent Resonance Innovations, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142676 | Siemens 3.0T PROCURE Array Coil | MOS | 2014-12-05 | 77 |
| K142755 | Siemens 3.0 Blanket Array Coil | MOS | 2014-10-23 | 28 |
| K140606 | 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL | MOS | 2014-05-12 | 63 |
| K140282 | ST SENSE NV 8 ARRAY COIL | MOS | 2014-02-26 | 22 |
| K133986 | 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY | MOS | 2014-01-27 | 32 |
| K130457 | 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL | MOS | 2013-05-20 | 87 |
| K061170 | 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 | MOS | 2006-05-25 | 28 |
| K060689 | 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL | MOS | 2006-03-31 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Resonance Innovations, LLC.
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 Innovations, LLC (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
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 Health Analysis Services Pty, Ltd. (6 510(k)s)
- Resonance Technology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Resonance Innovations, LLC?
FDA lists 8 510(k) clearances under the applicant name “Resonance Innovations, LLC” (first 2006, latest 2014), across 1 product code 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 Innovations, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Resonance Innovations, LLC is 30 days.
Which FDA product codes appear under Resonance Innovations, LLC?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 8).
Next steps
- See all 8 Resonance Innovations, LLC clearances with predicates and recalls
- Run predicate analysis for product code MOS, Resonance Innovations, LLC'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.