Scanditronix, Inc.: FDA clearances and approvals
Scanditronix, Inc. has 7 FDA 510(k) clearances (first 1984, latest 1994), across 5 product codes in 1 review panel. Median 510(k) review time: 88 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 3 | 3 |
| IWB | System, Radiation Therapy, Radionuclide | 1 | 1 |
| IWE | Monitor, Patient Position, Light-Beam | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
Review panels
- Radiology (7)
Most recent Scanditronix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934303 | RFA A-300 | IYE | 1994-08-09 | 342 |
| K942092 | DPD-3 | IYE | 1994-07-29 | 88 |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | IWB | 1993-01-04 | 83 |
| K914926 | SCANDIPLAN - VERSION 338 | KPQ | 1992-05-28 | 206 |
| K904753 | DIOLASE | IWE | 1990-11-09 | 21 |
| K900434 | MM-22 MICROTRON, MM50 MICROTRON | IYE | 1990-10-23 | 266 |
| K843366 | SUPERPETT | KPS | 1984-11-21 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Scanditronix, 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 Scanditronix, Inc. have?
Scanditronix, Inc. has 7 FDA 510(k) clearances (first 1984, latest 1994), across 5 product codes in 1 review panel.
How long does FDA take to clear Scanditronix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Scanditronix, Inc.'s cleared 510(k)s is 88 days.
What devices does Scanditronix, Inc. make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 3); IWB (System, Radiation Therapy, Radionuclide, 1); IWE (Monitor, Patient Position, Light-Beam, 1).
Has Scanditronix, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Scanditronix, Inc. Related entities may recall under other names.
Next steps
- See all 7 Scanditronix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Scanditronix, 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.