Danish Diagnostic Development A/S: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Danish Diagnostic Development A/S” (first 2000, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 | 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 5 | 5 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
Review panels
- Radiology (6)
Most recent Danish Diagnostic Development A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081829 | CAPIMAGE | IYX | 2008-07-11 | 14 |
| K051460 | C.CAM-AC | KPS | 2005-06-15 | 12 |
| K040616 | CARDIOMD-AC | KPS | 2004-03-24 | 15 |
| K031825 | C.CAM | KPS | 2003-06-20 | 7 |
| K011611 | CARDIOCAM MODEL 9CSY0799 | KPS | 2001-06-08 | 14 |
| K001888 | UNICORN MODEL SYS0630 | KPS | 2000-06-30 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Danish Diagnostic Development A/S.
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.
- Danish Dermatologic Development A/S (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Danish Diagnostic Development A/S?
FDA lists 6 510(k) clearances under the applicant name “Danish Diagnostic Development A/S” (first 2000, latest 2008), across 2 product codes 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 Danish Diagnostic Development A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Danish Diagnostic Development A/S is 14 days.
Which FDA product codes appear under Danish Diagnostic Development A/S?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 5); IYX (Camera, Scintillation (Gamma), 1).
Next steps
- See all 6 Danish Diagnostic Development A/S clearances with predicates and recalls
- Run predicate analysis for product code KPS, Danish Diagnostic Development A/S'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.