CAAS Workstation
FDA 510(k) K232147 · Pie Medical Imaging BV
510(k) numberK232147
Submission
- Device name
- CAAS Workstation
- Applicant
- Pie Medical Imaging BV
Maastricht, NL - Received
- July 19, 2023
- Decision date
- April 9, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QHA – X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1600
- Specialty
- Radiology
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…
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| K243769 | QFR (3.0)QHA · Traditional | Qfr Solutions BV | 04/04/2025SE |
| K230303 | AccuFFRangio PlusQHA · Special | ArteryFlow Technology Co., Ltd. | 03/02/2023SE |
| K221711 | AccuICASQHA · Traditional | ArteryFlow Technology Co., Ltd. | 02/28/2023SE |
| K210093 | AccuFFRangioQHA · Traditional | ArteryFlow Technology Co., Ltd. | 09/10/2021SE |
| K182611 | Qangio XA 3DQHA · Traditional | Medis Medical Imaging Systems BV | 05/30/2019SE |
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| K250330 | 3mensio WorkstationQIH · Traditional | 11/03/2025SE |
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| K181825 | CAAS MR SolutionsLLZ · Traditional | 12/04/2018SE |
| K180019 | CAAS WorkstationIZI · Traditional | 05/03/2018SE |
| K162376 | CAAS MR 4D FlowLLZ · Traditional | 12/08/2016SE |
| K162112 | Caas MRVLLZ · Traditional | 09/21/2016SE |
| K153736 | 3mensio WorkstationLLZ · Traditional | 05/27/2016SE |
| K151780 | CAAS WorkstationIZI · Traditional | 03/11/2016SE |
| K143044 | CAAS A-ValveLLZ · Traditional | 02/06/2015SE |
Questions and answers
When was CAAS Workstation cleared by the FDA?
CAAS Workstation (K232147) received a 510(k) decision of Substantially Equivalent on April 9, 2024, 265 days after the submission was received.
What is the product code of K232147?
The FDA product code is QHA – X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device, a Class II (moderate risk) device regulated under 21 CFR 892.1600.