The following data is part of a premarket notification filed by Neurologica Corporation, A Subsidiary Of Samsung Electronics with the FDA for Ceretom Elite.
| Device ID | K172539 |
| 510k Number | K172539 |
| Device Name: | CereTom Elite |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | NeuroLogica Corporation, A Subsidiary Of Samsung Electronics 14 Electronics Avenue Danvers, MA 01923 |
| Contact | Ninad Gujar |
| Correspondent | Ninad Gujar NeuroLogica Corporation, A Subsidiary Of Samsung Electronics 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 | 2017-08-23 |
| Decision Date | 2017-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815411020342 | K172539 | 000 |
| 10815411020595 | K172539 | 000 |
| 10815411020670 | K172539 | 000 |
| 10815411020182 | K172539 | 000 |
| 10815411020472 | K172539 | 000 |
| 10815411020496 | K172539 | 000 |
| 10815411020502 | K172539 | 000 |
| 10815411020519 | K172539 | 000 |
| 10815411020526 | K172539 | 000 |
| 10815411020540 | K172539 | 000 |
| 10815411020557 | K172539 | 000 |
| 10815411020564 | K172539 | 000 |
| 10815411020083 | K172539 | 000 |
| 10815411020175 | K172539 | 000 |
| 10815411020199 | K172539 | 000 |
| 10815411020304 | K172539 | 000 |
| 10815411020052 | K172539 | 000 |
| 10815411020687 | K172539 | 000 |