Radionics Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Radionics Medical, Inc.” (first 1981, latest 1985), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (2)
- Cardiovascular (1)
Most recent Radionics Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844299 | CORNEOMAP 4500 | IYO | 1985-04-18 | 162 |
| K833222 | SINUSVU 2500 | IYO | 1983-11-28 | 101 |
| K837331 | CORNEOMAP 4500 ULTRASOUND MEASUREMENT | — | 1983-05-09 | 60 |
| K827035 | OCULAR BIOMETER 4000 | — | 1982-07-22 | 90 |
| K810851 | SPECTRUM ANALYZER 8000 | DXG | 1981-04-23 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Radionics Medical, 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.
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.
- Radionics, Inc. (56 510(k)s)
- Radionics Software Applications, Inc. (12 510(k)s)
- Radionics, A Division of Tyco Healthcare Group LP (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radionics Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Radionics Medical, Inc.” (first 1981, latest 1985), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radionics Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radionics Medical, Inc. is 90 days.
Which FDA product codes appear under Radionics Medical, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 1).
Next steps
- See all 5 Radionics Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Radionics Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.