STRATIS

System, Nuclear Magnetic Resonance Imaging

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 Stratis.

Pre-market Notification Details

• Device ID: K945386
• 510k Number: K945386
• Device Name: STRATIS
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087
• Contact: James J Rogers
• Correspondent: James J Rogers; HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-03
• Decision Date: 1995-03-21