The following data is part of a premarket notification filed by General Electric Co. with the FDA for Magnetic Resonance Diagnostic Accessory.
| Device ID | K954353 |
| 510k Number | K954353 |
| Device Name: | MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL ELECTRIC CO. P0 BOX 414 Milwaukee, WI |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P0 BOX 414 Milwaukee, WI |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1996-04-12 |
| Summary: | summary |