The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Cp Breast Array Coil/magnetom Harmony/symphony System.
| Device ID | K973630 |
| 510k Number | K973630 |
| Device Name: | CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-24 |
| Decision Date | 1997-12-05 |
| Summary: | summary |