StrokeSENS ASPECTS Software Application
Summary
Circle Cardiovascular Imaging, Inc. received 510(k) clearance for StrokeSENS ASPECTS Software Application, a POK device. Cleared on 2025-07-01.
Details
Source
510(k) Clearance
External ID
K250221
Action Date
2025-07-01
Status
Traditional
Category
device
Product Code
POK
Product Description
StrokeSENS ASPECTS Software Application. Product code: POK.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Circle Cardiovascular Imaging, Inc. has received 5 total clearances in our database.
Circle Cardiovascular Imaging, Inc. has 5 FDA actions in our database, including 5 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Circle Cardiovascular Imaging, Inc. have FDA actions?
Circle Cardiovascular Imaging, Inc. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250221" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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