Is Cercare Medical Neurosuite FDA approved or cleared?
Yes. Cercare Medical Neurosuite by Cercare Medical A/S is named in the FDA register with a 510(k) clearance, latest decision in 2021.
In the EU: CE class IIb, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.
At a glance
| Product | Cercare Medical Neurosuite |
|---|---|
| Maker | Cercare Medical A/S |
| Care area | Imaging & AI diagnostics |
| What it does | Software for perfusion MRI and CT analysis, including AI detection of large vessel occlusion and intracranial bleeding |
| FDA | 510(k), latest decision 2021 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class IIb |
| EU certificate | Manufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026) |
| Website | cercare-medical.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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