Smart-C

Image-intensified Fluoroscopic X-ray System, Mobile

Turner Imaging Systems, Inc.

The following data is part of a premarket notification filed by Turner Imaging Systems, Inc. with the FDA for Smart-c.

Pre-market Notification Details

• Device ID: K190024
• 510k Number: K190024
• Device Name: Smart-C
• Classification: Image-intensified Fluoroscopic X-ray System, Mobile
• Applicant: Turner Imaging Systems, Inc. 1119 South 1680 West Orem, UT 84058
• Contact: Michael Drake
• Correspondent: D. Clark Turner; Turner Imaging Systems, Inc. 1119 South 1680 West Orem, UT 84058
• Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-07
• Decision Date: 2019-09-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850003909028	K190024	000
00850003909004	K190024	000