The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Clinical Phosphorus Spectroscopy Option/magnetom Vision System.
| Device ID | K962627 |
| 510k Number | K962627 |
| Device Name: | CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Spectroscopic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | LNI |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1997-04-03 |
| Summary: | summary |