Magnetic Research, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Magnetic Research, Inc.” (first 1991, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 203 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 | 8 | 8 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (9)
Most recent Magnetic Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935015 | QUADRATURE SMALL EXTREMITY COIL | LNH | 1994-05-10 | 203 |
| K932552 | SPORTS MEDICINE QUADRATURE SHOULDER COIL | LNH | 1994-02-09 | 259 |
| K932091 | PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL | LNH | 1993-12-14 | 228 |
| K931795 | TELERAD STAT | LMD | 1993-11-19 | 221 |
| K930991 | BILATERAL TEMPORAL MANDIBULAR JOINT COIL | LNH | 1993-06-18 | 113 |
| K923881 | QUADRATURE CERVICAL CONTOUR COIL | LNH | 1992-11-05 | 93 |
| K920227 | QUADRATURE SHOULDER CONTOUR COIL | LNH | 1992-08-24 | 220 |
| K922006 | QQUADRATURE LUMBAR CONTOUR COIL | LNH | 1992-07-29 | 90 |
| K905512 | ANTERIOR NECK CONTOUR COIL | LNH | 1991-03-07 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Magnetic Research, 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 Magnetic Research, 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)
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.
- Magnetic Resonance Equipment Corp. (5 510(k)s)
- Magnetic Moments, LLC (1 510(k)s)
- Magnetic Resonance Plus, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Magnetic Research, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Magnetic Research, Inc.” (first 1991, latest 1994), across 2 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 Magnetic Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Magnetic Research, Inc. is 203 days.
Which FDA product codes appear under Magnetic Research, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 8); LMD (System, Digital Image Communications, Radiological, 1).
Next steps
- See all 9 Magnetic Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Magnetic Research, 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.