MYOLIGHT

System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS F.I. HAIFA

The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Myolight.

Pre-market Notification Details

• Device ID: K033874
• 510k Number: K033874
• Device Name: MYOLIGHT
• Classification: System, Tomography, Computed, Emission
• Applicant: GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200
• Contact: Laurence Bigio
• Correspondent: Chantel Carson; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2003-12-15
• Decision Date: 2003-12-30
• Summary: summary