The following data is part of a premarket notification filed by Siemens Corp. with the FDA for High Ends Gradients/magnetom Symphony System.
| Device ID | K991652 |
| 510k Number | K991652 |
| Device Name: | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford SIEMENS CORP. 186 WOOD AVE., SOUTH Iselin, NJ 08830 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-13 |
| Decision Date | 1999-08-03 |
| Summary: | summary |