FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CINA-ASPECTS
K Number: K233342
·
Decision Mar 15, 2024
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
21
Applicant Total
7
Review Days
168
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Basic Information
- Device Name
- CINA-ASPECTS
- K Number
- K233342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avicenna.Ai
- Date Received
- September 29, 2023
- Decision Date
- March 15, 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 Avicenna.Ai
| K Number | Device Name | ||
|---|---|---|---|
| K240942 | CINA-CSpine | Sep 12, 2024 | Substantially Equivalent |
| K240612 | CINA-VCF | May 31, 2024 | Substantially Equivalent |
| K233968 | CINA-iPE | Mar 13, 2024 | Substantially Equivalent |
| K221716 | CINA | Nov 22, 2022 | Substantially Equivalent |
| K210237 | CINA CHEST | May 19, 2021 | Substantially Equivalent |
| K200855 | CINA | Jun 24, 2020 | Substantially Equivalent |