HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS

System, Imaging, Pulsed Echo, Ultrasonic

HITACHI MEDICAL SYSTEMS AMERICA, INC.

The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hi Vision Preirus Doagnostic Ultrasound Scanner Model Hi Vision Preirus.

Pre-market Notification Details

• Device ID: K093466
• 510k Number: K093466
• Device Name: HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087
• Contact: Dough Thistlethwaite
• Correspondent: Dough Thistlethwaite; HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087
• Product Code: IYO
• Subsequent Product Code: ITX
• Subsequent Product Code: IYN
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-11-06
• Decision Date: 2010-06-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04961333243891	K093466	000
04961333243143	K093466	000
04961333243136	K093466	000
04961333243129	K093466	000
04961333243112	K093466	000
04961333243105	K093466	000
04961333240357	K093466	000
04573596210888	K093466	000
04573596211564	K093466	000