The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Ii Rva.
| Device ID | K033920 |
| 510k Number | K033920 |
| Device Name: | CAAS II RVA |
| Classification | System, Image Processing, Radiological |
| Applicant | PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 DO1 Maastricht, NL 6216 Bx |
| Contact | Carla De Vries |
| Correspondent | Carla De Vries PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 DO1 Maastricht, NL 6216 Bx |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-18 |
| Decision Date | 2004-03-17 |
| Summary: | summary |