Identity
- Trade Name
- StrokeSENS EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- StrokeSENS EUDAMEDStrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. FDA UDI
- Model / Reference
- v1.4 EUDAMEDv1.x FDA UDI
- Description
- StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B926SSSX10 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B926SSSX10 EUDAMED
- 510(k) Number
- K212261 FDA UDI
- FDA Product Code
- QAS FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2080 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
StrokeSENS by Circle Cardiovascular Imaging Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-B926SSSX10 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Circle Cardiovascular Imaging Inc
- EUDAMED SRN
- CA-MF-000011835
- Authorised Representative
- QDossier B.V. NL-AR-000033747
Sources (2)
- EUDAMED 14350857-aa1f-4bc4-890d-2600b568e667 61 fields · synced Jul 26, 2026
- FDA UDI 53482d8b-5336-4b20-8b7b-48b1c888e3ee 34 fields · synced May 30, 2026