ViewPoint 6

System, Image Processing, Radiological

GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics with the FDA for Viewpoint 6.

Pre-market Notification Details

• Device ID: K162743
• 510k Number: K162743
• Device Name: ViewPoint 6
• Classification: System, Image Processing, Radiological
• Applicant: GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS 9900 W INNOVATION DRIVE Wauwatosa, WI 53226
• Contact: Tracey Ortiz
• Correspondent: Tracey Ortiz; GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS 9900 W INNOVATION DRIVE Wauwatosa, WI 53226
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-30
• Decision Date: 2016-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682124454	K162743	000
00840682119627	K162743	000