FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rapid ASPECTS (v3)
K Number: K232156
·
Decision Jan 19, 2024
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
21
Applicant Total
21
Review Days
183
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Basic Information
- Device Name
- Rapid ASPECTS (v3)
- K Number
- K232156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ischemaview, Inc.
- Date Received
- July 20, 2023
- Decision Date
- January 19, 2024
- 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 Ischemaview, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251987 | Rapid Aortic Measurements | Sep 23, 2025 | Substantially Equivalent |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OH | Sep 4, 2025 | Substantially Equivalent |
| K252526 | Rapid DeltaFuse | Aug 26, 2025 | Substantially Equivalent |
| K243378 | Rapid MLS | May 28, 2025 | Substantially Equivalent |
| K243350 | Rapid Neuro3D | Jan 22, 2025 | Substantially Equivalent |
| K233582 | Rapid | Apr 22, 2024 | Substantially Equivalent |
| K233512 | Rapid (6.0) | Jan 16, 2024 | Substantially Equivalent |
| K232436 | Rapid SDH | Oct 25, 2023 | Substantially Equivalent |
| K230074 | Rapid Aneurysm Triage and Notification | Jul 27, 2023 | Substantially Equivalent |
| K222884 | Rapid NCCT Stroke | Mar 2, 2023 | Substantially Equivalent |