The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge 0.2t Signa Profile Excite Mr System.
Device ID | K043112 |
510k Number | K043112 |
Device Name: | GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 W-400 Milwaukee, WI 53201 |
Contact | Larry A Kroger |
Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 W-400 Milwaukee, WI 53201 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-10 |
Decision Date | 2004-11-24 |
Summary: | summary |