The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for 3mensio Workstation.
| Device ID | K153736 |
| 510k Number | K153736 |
| Device Name: | 3mensio Workstation |
| Classification | System, Image Processing, Radiological |
| Applicant | Pie Medical Imaging B.V. Philipsweg 1 Maastricht, NL 6227 Aj |
| Contact | Annemiek Bouts |
| Correspondent | Annemeik 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 | 2015-12-28 |
| Decision Date | 2016-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056304454225 | K153736 | 000 |
| 08056304454348 | K153736 | 000 |
| 08056304454942 | K153736 | 000 |
| 08056304454669 | K153736 | 000 |
| 08056304454249 | K153736 | 000 |
| 08056304453488 | K153736 | 000 |
| 08056304453778 | K153736 | 000 |
| 08056304453839 | K153736 | 000 |
| 08056304451217 | K153736 | 000 |
| 08056304454072 | K153736 | 000 |
| 08056304455505 | K153736 | 000 |