OmniTom
System, X-ray, Tomography, Computed
NeuroLogica Corporation,
The following data is part of a premarket notification filed by Neurologica Corporation, with the FDA for Omnitom.
Pre-market Notification Details
| Device ID | K171183 |
| 510k Number | K171183 |
| Device Name: | OmniTom |
| 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 | 2017-04-24 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815411020335 | K171183 | 000 |
| 10815411020458 | K171183 | 000 |
| 10815411020441 | K171183 | 000 |
| 10815411020410 | K171183 | 000 |
| 10815411020403 | K171183 | 000 |
| 10815411020397 | K171183 | 000 |
Trademark Results [OmniTom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNITOM 87426561 5499125 Live/Registered |
NeuroLogica Corp. 2017-04-26 |
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