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: K122825
• 510k Number: K122825
• Device Name: ACUSON
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. 685 East Middlefield Road Mountain View, CA 94043
• Contact: Shelly Pearce
• 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: 2012-09-14
• Decision Date: 2012-09-28