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