The following data is part of a premarket notification filed by Ceremetrix Corp with the FDA for Ceremetrix Silver.
| Device ID | K173145 |
| 510k Number | K173145 |
| Device Name: | CereMetrix Silver |
| Classification | System, Image Processing, Radiological |
| Applicant | CereMetrix Corp 991 Southpark Drive , Suite 200 Littleton, CO 80120 |
| Contact | John A Kelley |
| Correspondent | John A Kelley CereMetrix Corp 991 Southpark Drive , Suite 200 Littleton, CO 80120 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-02-28 |