510(k) Premarket Notification

• Device Classification Name: system, nuclear magnetic resonance imaging
• 510(k) Number: K052293
• Device Name: GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
• Applicant: GE MEDICAL SYSTEMS, LLC; P.O. BOX 414; MILWAUKEE, WI 53201
• Applicant Contact: LARRY A KROGER, PH.D.
• Correspondent: GE MEDICAL SYSTEMS, LLC; P.O. BOX 414; MILWAUKEE, WI 53201
• Correspondent Contact: LARRY A KROGER, PH.D.
• Regulation Number: 892.1000
• Classification Product Code: LNH
• Date Received: 08/23/2005
• Decision Date: 09/21/2005
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Radiology
• 510k Review Panel: Radiology
• Summary: Summary
• Type: Special
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls