ACUSON

System, Imaging, Pulsed Doppler, Ultrasonic

SIEMENS MEDICAL SOLUTIONS USA INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Acuson.

Pre-market Notification Details

• Device ID: K123622
• 510k Number: K123622
• Device Name: ACUSON
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: SIEMENS MEDICAL SOLUTIONS USA INC. 685 EAST MIDDLEFIELD ROAD Mountain View, CA 94043 -0000
• Contact: Patrick Lynch
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• Subsequent Product Code: OBJ
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-11-23
• Decision Date: 2012-12-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056869005423	K123622	000