CAAS Workstation
FDA 510(k) K151780 · Pie Medical Imaging BV
510(k) numberK151780
Submission
- Device name
- CAAS Workstation
- Applicant
- Pie Medical Imaging BV
Maastricht, NL - Received
- July 1, 2015
- Decision date
- March 11, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Surgvision GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K250330 | 3mensio WorkstationQIH · Traditional | 11/03/2025SE |
| K232147 | CAAS WorkstationQHA · Traditional | 04/09/2024SE |
| K232007 | CAAS MR SolutionsLLZ · Traditional | 02/01/2024SE |
| K212376 | Caas QardiaLLZ · Traditional | 05/16/2022SE |
| 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 |
| K143044 | CAAS A-ValveLLZ · Traditional | 02/06/2015SE |
Questions and answers
When was CAAS Workstation cleared by the FDA?
CAAS Workstation (K151780) received a 510(k) decision of Substantially Equivalent on March 11, 2016, 254 days after the submission was received.
What is the product code of K151780?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.