FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CINA CHEST
K Number: K210237
·
Decision May 19, 2021
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
7
Review Days
111
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Basic Information
- Device Name
- CINA CHEST
- K Number
- K210237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avicenna.Ai
- Date Received
- January 28, 2021
- Decision Date
- May 19, 2021
- 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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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 |
| K233342 | CINA-ASPECTS | Mar 15, 2024 | Substantially Equivalent |
| K233968 | CINA-iPE | Mar 13, 2024 | Substantially Equivalent |
| K221716 | CINA | Nov 22, 2022 | Substantially Equivalent |
| K200855 | CINA | Jun 24, 2020 | Substantially Equivalent |