NOBLUS™ Ultrasound Diagnostic System

System, Imaging, Pulsed Doppler, Ultrasonic

HITACHI MEDICAL CORPORATION

The following data is part of a premarket notification filed by Hitachi Medical Corporation with the FDA for Noblus™ Ultrasound Diagnostic System.

Pre-market Notification Details

• Device ID: K160559
• 510k Number: K160559
• Device Name: NOBLUS™ Ultrasound Diagnostic System
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: HITACHI MEDICAL CORPORATION 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502
• Contact: Angela Van Arsdale
• Correspondent: Angela Van Arsdale; HITACHI MEDICAL CORPORATION 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502
• 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: 2016-02-29
• Decision Date: 2016-10-18
• Summary: summary