The following data is part of a premarket notification filed by Anatomage, Inc with the FDA for Cephsimulation.
| Device ID | K161270 |
| 510k Number | K161270 |
| Device Name: | CephSimulation |
| Classification | System, Image Processing, Radiological |
| Applicant | ANATOMAGE, INC 111N. MARKET ST, #500 San Jose, CA 95113 |
| Contact | Changxin Xu |
| Correspondent | Changxin Xu ANATOMAGE, INC 303 Almaden Blvd #700 San Jose, CA 95110 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2017-01-04 |
| Summary: | summary |