FDA.report

510(k) K250221

Device
StrokeSENS ASPECTS Software Application
Applicant
Circle Cardiovascular Imaging, Inc.
510(k) number
K250221
Product code
POK
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-01
Date received
2025-01-24
Regulation
892.2060
Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Kyle Mayr
Address
Suite 1800, 707 8 Ave. SW Calgary CA T2P 1H5 T2P 1H5

FDA Registration Numbers

Source Documents

510(k) summary PDF

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