Vscan Extend

System, Imaging, Pulsed Doppler, Ultrasonic

GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc with the FDA for Vscan Extend.

Pre-market Notification Details

• Device ID: K161588
• 510k Number: K161588
• Device Name: Vscan Extend
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC 9900 W. INNOVATION DRIVE Wauwatosa, WI 53226
• Contact: Tracey Ortiz
• Correspondent: Tracey Ortiz; GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC 9900 W. INNOVATION DRIVE Wauwatosa, WI 53226
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-08
• Decision Date: 2016-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682121651	K161588	000