C-Rad Positioning AB: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “C-Rad Positioning AB” (first 2007, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 92 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 | 2 | 130 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 58 |
| 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 C-Rad Positioning AB took a median 58 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 | 6 | 6 |
Review panels
- Radiology (6)
Most recent C-Rad Positioning AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200435 | Catalyst+, Catalyst+ HD | IYE | 2020-05-07 | 73 |
| K200600 | Sentinel | IYE | 2020-04-20 | 42 |
| K120668 | SENTINEL | IYE | 2012-07-30 | 147 |
| K113276 | CATALYST | IYE | 2012-02-27 | 112 |
| K082582 | SENTINEL, MODEL SP-001 | IYE | 2009-03-30 | 203 |
| K063839 | POSITIONER | IYE | 2007-02-08 | 44 |
Recalls
3 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2025-10-09.
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 C-Rad Positioning AB?
FDA lists 6 510(k) clearances under the applicant name “C-Rad Positioning AB” (first 2007, latest 2020), 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 C-Rad Positioning AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name C-Rad Positioning AB is 92 days.
Which FDA product codes appear under C-Rad Positioning AB?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 6).
Next steps
- See all 6 C-Rad Positioning AB clearances with predicates and recalls
- Run predicate analysis for product code IYE, C-Rad Positioning 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.