The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Workstation.
| Device ID | K151780 |
| 510k Number | K151780 |
| Device Name: | CAAS Workstation |
| Classification | System, X-ray, Angiographic |
| Applicant | PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht, NL 6227 Aj |
| Contact | Florie Daniels |
| Correspondent | Florie Daniels PIE MEDICAL IMAGING B.V. 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 | 2015-07-01 |
| Decision Date | 2016-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304451200 | K151780 | 000 |
| 08056304453761 | K151780 | 000 |
| 08056304453440 | K151780 | 000 |
| 08056304453099 | K151780 | 000 |