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StrokeSENS

by Circle Cardiovascular Imaging Inc 2 variants

Ref v2.x

StrokeSENS (v2.x) is a CT system application software (EU MDR Class IIa; FDA Class II) made by Circle Cardiovascular Imaging, cleared under FDA 510(k) K250221 on 1 Jul 2025 (1 earlier submission), registered in EUDAMED on 20 Feb 2025 (Basic UDI-DI 882916SSX6N) and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 00882916001025), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250221

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK250221 Date1 Jul 2025DecidedStatusActive
European UnionCE/MDR EUDAMED Number882916SSX6N Basic UDI-DI 00882916001025UDI-DIDate20 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00882916001025 UDI-DI Date5 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • FDA 510(k) K250221 decided 1 Jul 2025 Active· +1 more in the status table
  • EUDAMED Basic UDI-DI 882916SSX6N registered 20 Feb 2025 Active
  • FDA GUDID UDI-DI 00882916001025 listed 5 Feb 2025 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K212261
  2. Listed FDA GUDID 00882916001025
  3. Registered EUDAMED 882916SSX6N
  4. Cleared FDA 510(k) K250221

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
StrokeSENS EUDAMED
StrokeSENS LVO GUDID
Generic name
CT system application software
Model / reference
v2.x
Primary DI / UDI-DI
00882916001025
Basic UDI-DI
882916SSX6N
Direct marketing DI
00882916001025
510(k) Number
FDA product code
QAS, POK
EMDN code
Z11030682 Computed tomographs (CT) - software accessories
GMDN term
CT system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2080, 892.2060
Special device type
Software
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CA-MF-000011835
Authorised representative
QDossier B.V. NL-AR-000033747

Related devices

Category: Full-body CT system

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES.

Other devices from Circle Cardiovascular Imaging

See all devices from Circle Cardiovascular Imaging →

Properties

  • Prescription use
  • Manufacturing date
Other properties (23, all answered No)