Quicktome

System, Image Processing, Radiological

Omniscient Neurotechnology Pty Ltd (o8t)

The following data is part of a premarket notification filed by Omniscient Neurotechnology Pty Ltd (o8t) with the FDA for Quicktome.

Pre-market Notification Details

• Device ID: K203518
• 510k Number: K203518
• Device Name: Quicktome
• Classification: System, Image Processing, Radiological
• Applicant: Omniscient Neurotechnology Pty Ltd (o8t) Level 10, 580 George Street Sydney, AU 2000
• Contact: Arie Henkin
• Correspondent: Arie Henkin; Omniscient Neurotechnology Pty Ltd (o8t) Level 10, 580 George Street Sydney, AU 2000
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-01
• Decision Date: 2021-03-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09358140000017	K203518	000
09358140000024	K203518	000
09358140000048	K203518	000