The following data is part of a premarket notification filed by Neurologica Corporation, A Subsidiary Of Samsung Electronics with the FDA for Omnitom Elite.
| Device ID | K211711 |
| 510k Number | K211711 |
| Device Name: | OmniTom Elite |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NeuroLogica Corporation, A Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers, MA 01923 |
| Contact | Ninad Gujar |
| Correspondent | Ninad Gujar NeuroLogica Corporation, A Subsidiary Of Samsung Electronics Co., Ltd 14 Electronics Avenue Danvers, MA 01923 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2022-02-25 |