Resonex, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Resonex, Inc.” (first 1988, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 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 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 21 | 21 |
Review panels
- Radiology (21)
Most recent Resonex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935369 | FAST SPIN ECHO (FSE) | LNH | 1994-03-21 | 137 |
| K935570 | NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM | LNH | 1994-03-16 | 118 |
| K931392 | ECG GATING UNIT | LNH | 1993-11-02 | 228 |
| K923870 | 3DTOF MRA | LNH | 1993-01-12 | 162 |
| K924154 | KINEMATIC MRI MOVIEMAKER | LNH | 1992-11-23 | 97 |
| K923823 | 3D IMAGING | LNH | 1992-10-30 | 92 |
| K922677 | MAGNETIZATION TRANSFER CONTRAST | LNH | 1992-09-04 | 92 |
| K920254 | COILS FOR RX4000 & RX5000 MRI SYSTEMS | LNH | 1992-06-22 | 153 |
| K921046 | BO POWER SUPPLY | LNH | 1992-05-28 | 85 |
| K920835 | PRESATURATION | LNH | 1992-05-22 | 88 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Resonex, Inc..
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 Resonex, Inc. (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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Resonex, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Resonex, Inc.” (first 1988, latest 1994), 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 Resonex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Resonex, Inc. is 85 days.
Which FDA product codes appear under Resonex, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 21).
Next steps
- See all 21 Resonex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Resonex, Inc.'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.