The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Mr Solutions.
| Device ID | K181825 |
| 510k Number | K181825 |
| Device Name: | CAAS MR Solutions |
| Classification | System, Image Processing, Radiological |
| Applicant | Pie Medical Imaging B.V. Philipsweg 1 Maastricht, NL 6227 Aj |
| Contact | Annemiek Bouts |
| Correspondent | Annemiek Bouts Pie Medical Imaging B.V. Philipsweg 1 Maastricht, NL 6227 Aj |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304453969 | K181825 | 000 |
| 08056304454041 | K181825 | 000 |
| 08056304454256 | K181825 | 000 |
| 08056304454706 | K181825 | 000 |