SIGNA PROFILE

System, Nuclear Magnetic Resonance Imaging

GE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Signa Profile.

Pre-market Notification Details

• Device ID: K945730
• 510k Number: K945730
• Device Name: SIGNA PROFILE
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188
• Contact: Larry A Kroger
• Correspondent: Larry A Kroger; GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-22
• Decision Date: 1995-08-09