Scandidos AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Scandidos AB” (first 2006, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 107 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 | 1 | 107 |
| 2016 | 1 | 246 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 103 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 454 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scandidos AB took a median 278 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
Review panels
- Radiology (5)
Most recent Scandidos AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223234 | Delta4 Insight | IYE | 2024-01-16 | 454 |
| K183606 | Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) | IYE | 2019-04-08 | 103 |
| K151426 | ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ | IYE | 2016-01-29 | 246 |
| K151180 | ScandiDos Delta4 Phantom+ | IYE | 2015-08-19 | 107 |
| K052920 | DELTA4 | IYE | 2006-01-12 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Scandidos AB.
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 Scandidos AB?
FDA lists 5 510(k) clearances under the applicant name “Scandidos AB” (first 2006, latest 2024), across 1 product code 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 Scandidos AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scandidos AB is 107 days.
Which FDA product codes appear under Scandidos AB?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 5).
Next steps
- See all 5 Scandidos AB clearances with predicates and recalls
- Run predicate analysis for product code IYE, Scandidos AB'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.