FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rapid Obstructive Hydrocephalus, Rapid OH
K Number: K251533
·
Decision Sep 4, 2025
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
21
Review Days
108
Basic Information
- Device Name
- Rapid Obstructive Hydrocephalus, Rapid OH
- K Number
- K251533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ischemaview, Inc.
- Date Received
- May 19, 2025
- Decision Date
- September 4, 2025
- Product Code
- QAS
- 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 |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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|---|---|---|---|
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| K233582 | Rapid | Apr 22, 2024 | Substantially Equivalent |
| K232156 | Rapid ASPECTS (v3) | Jan 19, 2024 | Substantially Equivalent |
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| K232436 | Rapid SDH | Oct 25, 2023 | Substantially Equivalent |
| K230074 | Rapid Aneurysm Triage and Notification | Jul 27, 2023 | Substantially Equivalent |
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