Radiomed Corporation: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Radiomed Corporation” (first 2000, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 35 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 | 1 | 28 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 310 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Radiomed Corporation took a median 310 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
Review panels
- Radiology (7)
Most recent Radiomed Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) | IYE | 2017-04-28 | 310 |
| K120859 | PRE-LOADED GOLD VISICOIL CK MARKER | KXK | 2012-04-19 | 28 |
| K070305 | PRE-LOADED VISICOIL | IYE | 2007-03-07 | 34 |
| K031206 | RADIOMED SOFT TISSUE MARKER | JAK | 2003-05-21 | 35 |
| K022326 | RADIOMED MARKER | JAK | 2003-01-31 | 197 |
| K013660 | GENETRA | KXK | 2001-12-05 | 29 |
| K001070 | RADIOMED SOURCE | KXK | 2000-10-24 | 204 |
Recalls
openFDA lists no recalls under a recalling firm named Radiomed Corporation.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiomed Corporation?
FDA lists 7 510(k) clearances under the applicant name “Radiomed Corporation” (first 2000, latest 2017), 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 Radiomed Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiomed Corporation is 35 days.
Which FDA product codes appear under Radiomed Corporation?
The most frequent FDA product codes under this applicant name are KXK (Source, Brachytherapy, Radionuclide, 3); IYE (Accelerator, Linear, Medical, 2); JAK (System, X-Ray, Tomography, Computed, 2).
Next steps
- See all 7 Radiomed Corporation clearances with predicates and recalls
- Run predicate analysis for product code KXK, Radiomed Corporation'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.