K180019 is an FDA 510(k) clearance for the CAAS Workstation. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Pie Medical Imaging BV (Maastricht, NL). The FDA issued a Cleared decision on May 3, 2018, 121 days after receiving the submission on January 2, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K180019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2018 |
| Decision Date | May 03, 2018 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |