510(k) K232147
K232147 is an FDA 510(k) premarket notification submitted by Pie Medical Imaging BV for the device "CAAS Workstation". The FDA issued a decision of Substantially Equivalent on April 9, 2024. 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. Pie Medical Imaging BV has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2024
- Date Received
- July 19, 2023
- 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.