The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Mrv Version 3.0.
| Device ID | K060941 |
| 510k Number | K060941 |
| Device Name: | CAAS MRV VERSION 3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | PIE MEDICAL IMAGING B.V. 7450 FLYING CLOUD DR. Eden Prairie, MN 55344 |
| Contact | Carl M Beaurline |
| Correspondent | Carl M Beaurline PIE MEDICAL IMAGING B.V. 7450 FLYING CLOUD DR. Eden Prairie, MN 55344 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304451163 | K060941 | 000 |