The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Mr 2002b.
| Device ID | K020991 |
| 510k Number | K020991 |
| Device Name: | SYNGO MR 2002B |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Jamie Yieh |
| Correspondent | Jamie Yieh SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE 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 | 2002-03-27 |
| Decision Date | 2002-06-13 |
| Summary: | summary |