The following data is part of a premarket notification filed by General Electric Co. with the FDA for Vectra Magnetic Resonance System.
Device ID | K913673 |
510k Number | K913673 |
Device Name: | VECTRA MAGNETIC RESONANCE SYSTEM |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Larry Kroger |
Correspondent | Larry Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-19 |
Decision Date | 1992-01-23 |