The following data is part of a premarket notification filed by Siemens Medical Corp. with the FDA for Magnetom Open Viva With Permanent Magnet.
| Device ID | K994316 |
| 510k Number | K994316 |
| Device Name: | MAGNETOM OPEN VIVA WITH PERMANENT MAGNET |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Jamie Yieh |
| Correspondent | Jamie Yieh SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-01-14 |
| Summary: | summary |