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FDA 510(k)

StrokeSENS ASPECTS Software Application

K-Number: K250221 · 2025-07-01

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2025-07-01
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

StrokeSENS ASPECTS Software Application is a medical device manufactured by Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2025-07-01 under approval number K250221. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StrokeSENS ASPECTS Software Application?

StrokeSENS ASPECTS Software Application is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Circle Cardiovascular Imaging, Inc.. The 510(k) number is K250221.

When was StrokeSENS ASPECTS Software Application approved by the FDA?

StrokeSENS ASPECTS Software Application received FDA 510(k) clearance on 2025-07-01, under approval number K250221.

What company makes StrokeSENS ASPECTS Software Application?

StrokeSENS ASPECTS Software Application is manufactured by Circle Cardiovascular Imaging, Inc..

What is the FDA product code for StrokeSENS ASPECTS Software Application?

The FDA product code for StrokeSENS ASPECTS Software Application is POK.

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Related PubMed Literature

PMID: 41967338 Patient-tailored brachytherapy applicator development in compliance with the EU medical device regulation. Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) (2026) PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 40246727 [Discussion on Registration Evaluation Concerns of Embolic Microsphere Devices]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Circle Cardiovascular Imaging, Inc.

K202212TruPlan K213998cvi42 Auto Imaging Software Application K222593TruPlan Computed Tomography (CT) Imaging Software K242781cvi42 Software Application K251027cvi42 Coronary Plaque Software Application

Related Devices (Code: POK)

DEN170022QuantXQuantitative Insights, Inc. K190442Koios DS for BreastKoios Medical, Inc. K201555EchoGo ProUltromics, Ltd. K200760Rapid ASPECTSIschemaview, Inc. K212616Koios DSKoios Medical, Inc. K202300Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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