The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for 3mensio Workstation.
| Device ID | K120367 |
| 510k Number | K120367 |
| Device Name: | 3MENSIO WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht, NL 6216 Bx |
| Contact | Florie Daniels |
| Correspondent | Florie Daniels PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D 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 | 2012-02-06 |
| Decision Date | 2012-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304451224 | K120367 | 000 |
| 08056304453495 | K120367 | 000 |