The following data is part of a premarket notification filed by Neurologica Corporation with the FDA for Nexct 7.
| Device ID | K142697 |
| 510k Number | K142697 |
| Device Name: | NExCT 7 |
| 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 | 2014-09-22 |
| Decision Date | 2014-12-23 |
| Summary: | summary |