Versana Balance

System, Imaging, Pulsed Doppler, Ultrasonic

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 Versana Balance.

Pre-market Notification Details

• Device ID: K220446
• 510k Number: K220446
• Device Name: Versana Balance
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226
• Contact: Tracey Ortiz
• Correspondent: Lee Bush; GE Medical Systems Ultrasound And 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: 2022-02-16
• Decision Date: 2022-05-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195278300096	K220446	000
00195278300034	K220446	000