Data / Medical devices / Denmark / Cercare Medical A/S
Cercare Medical A/S: FDA-registered device maker in Aarhus Midtjylland, Denmark, 5 510(k) clearances
Cercare Medical A/S is registered with the FDA (registration 3019844085) in Aarhus Midtjylland, Denmark. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019844085
- Address
- Inge Lehmanns Gade 10, Aarhus Midtjylland, Denmark, 8000
- Owner or operator
- Cercare Medical (10082009)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 4, 2021
- Registered through
- 2026
- Brand names listed
- CMN Capillary Function with Oncology Virtual Expert, CMN Capillary Function with Virtual Expert, Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert, Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert for MRI, CT and CBCT, Cercare Medical Neurosuite (CMN) with Capillary Function, Cercare Oncology Virtual Expert, Cercare Perfusion (MRI), Cercare Stroke (MRI)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| June 22, 2026 | K260316 | CMN Capillary Function with Oncology Virtual Expert | QIH | Substantially Equivalent | Cercare Medical A/S | accessdata.fda.gov |
| May 18, 2026 | K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | LLZ | Substantially Equivalent | Cercare Medical A/S | accessdata.fda.gov |
| December 6, 2024 | K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | LLZ | Substantially Equivalent | Cercare Medical A/S | accessdata.fda.gov |
| July 14, 2023 | K230016 | Cercare Medical Neurosuite | LLZ | Substantially Equivalent | Cercare Medical A/S | accessdata.fda.gov |
| May 17, 2021 | K202793 | Cercare Medical Neurosuite | LLZ | Substantially Equivalent | Cercare Medical Aps | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated June 22, 2026. 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.