This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | GYROSCAN(TM) |
| Generic Name | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. |
| Date Received | 1987-05-06 |
| Decision Date | 1987-08-11 |
| PMA | P840063 |
| Supplement | S005 |
| Product Code | LNH |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PHILIPS MEDICAL SYSTEMS, INC. 710 Bridgeport Ave. p.o. Box 860 shelton, CT 06484 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840063 | Original Filing | |
| S007 | 1987-11-05 | Normal 180 Day Track |
| S006 | 1987-11-05 | Normal 180 Day Track |
| S005 | 1987-05-06 | Normal 180 Day Track |
| S004 | 1987-04-08 | Special (immediate Track) |
| S003 | 1986-11-07 | Normal 180 Day Track |
| S002 | 1986-10-31 | Normal 180 Day Track |
| S001 | 1986-10-16 | Normal 180 Day Track |