FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
AccuICAS
K Number: K221711
·
Decision Feb 28, 2023
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
6
Review Days
260
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Basic Information
- Device Name
- AccuICAS
- K Number
- K221711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ArteryFlow Technology Co., Ltd.
- Date Received
- June 13, 2022
- Decision Date
- February 28, 2023
- Product Code
- QHA
- 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 |
|---|---|---|---|
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | FDA class 2 | Radiology |
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Other Clearances by ArteryFlow Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231353 | AccuCTP Pro | Sep 14, 2023 | Substantially Equivalent |
| K230303 | AccuFFRangio Plus | Mar 2, 2023 | Substantially Equivalent |
| K220663 | AccuCTP | Nov 22, 2022 | Substantially Equivalent |
| K213838 | AneuGuide | Jun 1, 2022 | Substantially Equivalent |
| K210093 | AccuFFRangio | Sep 10, 2021 | Substantially Equivalent |