Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

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 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18.

Pre-market Notification Details

• Device ID: K220358
• 510k Number: K220358
• Device Name: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 Innovation Dr. Wauwatosa, WI 53226
• Contact: Bryan Behn
• Correspondent: Bryan Behn; GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 Innovation Dr. 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: 2022-02-08
• Decision Date: 2022-06-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195278347497	K220358	000
00195278347480	K220358	000
00195278347473	K220358	000
00195278283375	K220358	000
00195278699848	K220358	000
00195278699824	K220358	000
00195278699800	K220358	000
00195278677587	K220358	000