The following data is part of a premarket notification filed by Exocad Gmbh with the FDA for Exoplan 2.3.
| Device ID | K183458 |
| 510k Number | K183458 |
| Device Name: | Exoplan 2.3 |
| Classification | System, Image Processing, Radiological |
| Applicant | exocad GmbH 37, Julius-Reiber-Str. Darmstadt, DE 64293 |
| Contact | Stefan Walter |
| Correspondent | Stefan Walter exocad GmbH 37, Julius-Reiber-Str. Darmstadt, DE 64293 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-13 |
| Decision Date | 2019-08-06 |