The following data is part of a premarket notification filed by Neurologica Corporation, with the FDA for Bodytom 64.
| Device ID | K213649 |
| 510k Number | K213649 |
| Device Name: | BodyTom 64 |
| 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 | 2021-11-19 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815411020533 | K213649 | 000 |