MAGNISCAN 5000 MRI SYSTEM
FDA premarket approval P850043/S001 · decided 1987-12-30
Approval details
- PMA number
- P850043
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAGNISCAN 5000 MRI SYSTEM
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Thomson-Cgr Medical Corp.
- Date received
- 1987-08-07
- Decision date
- 1987-12-30
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Columbia, MD
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| STEREOTIX (K873618) | Thomson-Cgr Medical Corp. | 1987-11-16 |
| MPG-50 X-RAY GENERATOR (K873544) | Thomson-Cgr Medical Corp. | 1987-10-26 |
| DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM (K852353) | Thomson-Cgr Medical Corp. | 1985-08-07 |