K231353
- 510(k) number
- K231353
- Device name
- AccuCTP Pro
- Applicant
- ArteryFlow Technology Co., Ltd. CN
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-09-14
- Date received
- 2023-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K231353.pdf
Official FDA record: K231353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.