OpenSight

System, Image Processing, Radiological

Novarad Corporation

The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Opensight.

Pre-market Notification Details

• Device ID: K172418
• 510k Number: K172418
• Device Name: OpenSight
• Classification: System, Image Processing, Radiological
• Applicant: Novarad Corporation 752 East 1180 South #200 American Fork, UT 84003
• Contact: Doug Merrill
• Correspondent: Doug Merrill; Novarad Corporation 752 East 1180 South #200 American Fork, UT 84003
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-10
• Decision Date: 2018-09-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B109OPENSIGHT180760	K172418	000
B109OPENSIGHT188040	K172418	000
B109OPENSIGHT187060	K172418	000