ALTAIRE

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 Altaire.

Pre-market Notification Details

• Device ID: K050602
• 510k Number: K050602
• Device Name: ALTAIRE
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087
• Contact: Doug Thistlethwaite
• Correspondent: Doug Thistlethwaite; HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-09
• Decision Date: 2005-04-07
• Summary: summary