510(k) K210093
K210093 is an FDA 510(k) premarket notification submitted by ArteryFlow Technology Co., Ltd. for the device "AccuFFRangio". The FDA issued a decision of Substantially Equivalent on September 10, 2021. The device falls under product code QHA (X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device), a Class II device regulated under 21 CFR 892.1600. ArteryFlow Technology Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2021
- Date Received
- January 14, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type
X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.