MAGNETOM
FDA premarket approval P830081/S012 · decided 1987-04-10
Approval details
- PMA number
- P830081
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- MAGNETOM
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Siemens Corp.
- Date received
- 1987-03-19
- Decision date
- 1987-04-10
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Iselin, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (K103360) | Siemens Corp. | 2010-12-17 |
| KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY (K993947) | Siemens Corp. | 1999-12-21 |
| AX WORKSTATION DR-VIEWER SOFTWARE OPTION (K992925) | Siemens Corp. | 1999-11-23 |
| HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM (K991652) | Siemens Corp. | 1999-08-03 |
| SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION (K991600) | Siemens Corp. | 1999-06-09 |
| FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR (K984221) | Siemens Corp. | 1999-02-12 |
| PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS (K984224) | Siemens Corp. | 1999-02-02 |
| PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE (K982536) | Siemens Corp. | 1998-11-24 |