The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Breast Biopsy Device/magnetom Systems.
| Device ID | K010773 |
| 510k Number | K010773 |
| Device Name: | BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS |
| 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 | 2001-03-14 |
| Decision Date | 2001-05-30 |