FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
StrokeSENS ASPECTS Software Application
K Number: K250221
·
Decision Jul 1, 2025
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
21
Applicant Total
9
Review Days
158
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Basic Information
- Device Name
- StrokeSENS ASPECTS Software Application
- K Number
- K250221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Circle Cardiovascular Imaging, Inc.
- Date Received
- January 24, 2025
- Decision Date
- July 1, 2025
- Product Code
- POK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | FDA class 2 | Radiology |
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Other Clearances by Circle Cardiovascular Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251027 | cvi42 Coronary Plaque Software Application | Oct 27, 2025 | Substantially Equivalent |
| K242781 | cvi42 Software Application | Oct 15, 2024 | Substantially Equivalent |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | Jan 18, 2023 | Substantially Equivalent |
| K213998 | cvi42 Auto Imaging Software Application | Jul 28, 2022 | Substantially Equivalent |
| K202212 | TruPlan | Feb 19, 2021 | Substantially Equivalent |
| K141480 | CVI42 | Aug 22, 2014 | Substantially Equivalent |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | Aug 23, 2011 | Substantially Equivalent |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Nov 20, 2008 | Substantially Equivalent |