The following data is part of a premarket notification filed by Pie Medical Imaging Bv with the FDA for Caas Workstation.
| Device ID | K180019 |
| 510k Number | K180019 |
| Device Name: | CAAS Workstation |
| Classification | System, X-ray, Angiographic |
| Applicant | Pie Medical Imaging BV Philipsweg 1 Maastricht, NL 6227 Aj |
| Contact | Annemiek Bouts |
| Correspondent | Annemiek Bouts Pie Medical Imaging BV Philipsweg 1 Maastricht, NL 6227 Aj |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304454058 | K180019 | 000 |
| 08056304454003 | K180019 | 000 |
| 08056304454331 | K180019 | 000 |
| 08056304454461 | K180019 | 000 |
| 08056304455314 | K180019 | 000 |