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 | GYREX, MODELS S3500 & S5000 |
| Generic Name | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ELSCINT, INC. |
| Date Received | 1987-07-01 |
| Decision Date | 1987-10-08 |
| PMA | P840007 |
| Supplement | S002 |
| 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 | ELSCINT, INC. 930 Commonwealth Ave. boston, MA 02215 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840007 | Original Filing | |
| S003 | 1988-01-29 | Normal 180 Day Track |
| S002 | 1987-07-01 | Normal 180 Day Track |
| S001 | 1986-12-31 | Normal 180 Day Track |