Radionics Software Applications, Inc.: FDA clearances and approvals
Radionics Software Applications, Inc. has 12 FDA 510(k) clearances (first 1993, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time: 118 days.
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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 6 | 6 |
| IYE | Accelerator, Linear, Medical | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
Most recent Radionics Software Applications, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990326 | OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII | HAW | 1999-03-04 | 30 |
| K974602 | OPTICAL TRACKING SYSTEM (OTS) | HAW | 1998-04-21 | 133 |
| K972905 | XPLAN-1 | IYE | 1997-10-28 | 83 |
| K964801 | OPTICAL TRACKING SYSTEM (OTS) | HAW | 1997-06-02 | 185 |
| K961844 | OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] | HAW | 1996-10-23 | 163 |
| K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY | IYE | 1996-08-22 | 79 |
| K960071 | IMAGEFUSION | LLZ | 1996-04-17 | 103 |
| K951262 | OPERATING ARM SYSTEM (OAS) | LLZ | 1995-11-13 | 237 |
| K944463 | CRW-1 SYSTEM | HAW | 1995-10-26 | 409 |
| K953482 | XKNIFE-3 | IYE | 1995-10-25 | 93 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radionics Software Applications, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Radionics Software Applications, Inc. have?
Radionics Software Applications, Inc. has 12 FDA 510(k) clearances (first 1993, latest 1999), across 3 product codes in 2 review panels.
How long does FDA take to clear Radionics Software Applications, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Radionics Software Applications, Inc.'s cleared 510(k)s is 118 days.
What devices does Radionics Software Applications, Inc. make?
Its most frequent FDA product codes are HAW (Neurological Stereotaxic Instrument, 6); IYE (Accelerator, Linear, Medical, 4); LLZ (System, Image Processing, Radiological, 2).
Has Radionics Software Applications, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Radionics Software Applications, Inc. Related entities may recall under other names.
Next steps
- See all 12 Radionics Software Applications, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Radionics Software Applications, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.