Data / Medical devices / Denmark / X3D Aps
X3D Aps: FDA-registered device maker in Kvistgaard Hovedstaden, Denmark, 4 510(k) clearances
X3D Aps is registered with the FDA (registration 3030186509) in Kvistgaard Hovedstaden, Denmark. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 20, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030186509
- Address
- Oldenvej 33, Kvistgaard Hovedstaden, Denmark, 3490
- Owner or operator
- X3D ApS (10089603)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 22, 2023
- Registered through
- 2026
- Brand names listed
- Body MD, BodyMD, C.CAM, CARDIO MD, CapIMAGE, CardioMD, CorCam, QuantumCam and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 20, 2016 | K161674 | QuantumCam | KPS | Substantially Equivalent | Ddd-Diagnostic A/S | accessdata.fda.gov |
| July 11, 2008 | K081829 | CAPIMAGE | IYX | Substantially Equivalent | Danish Diagnostic Development A/S | accessdata.fda.gov |
| June 20, 2003 | K031825 | C.CAM | KPS | Substantially Equivalent | Danish Diagnostic Development A/S | accessdata.fda.gov |
| June 8, 2001 | K011611 | CARDIOCAM MODEL 9CSY0799 | KPS | Substantially Equivalent | Danish Diagnostic Development A/S | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.