FDA 510(k), K030874, GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM

510(K) Number: K030874
Device Name: GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
Manufacturer: LARRY A KROGER
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 03/20/2003
Decision Date: 03/28/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

150 pages (484 of 634 original pages are fully redacted)