GYREX, MODELS S3500 & S5000
FDA premarket approval P840007/S001 · decided 1987-04-02
Approval details
- PMA number
- P840007
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GYREX, MODELS S3500 & S5000
- Generic name
- System, nuclear magnetic resonance imaging
- Applicant
- Elscint, Inc.
- Date received
- 1986-12-31
- Decision date
- 1987-04-02
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LNH
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Boston, MA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY (K983313) | Elscint, Inc. | 1998-12-11 |
| VOLUMAX CT IMAGING SYSTEM (K982060) | Elscint, Inc. | 1998-09-02 |
| CT SCOPE (K974344) | Elscint, Inc. | 1998-06-03 |
| GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP (K980306) | Elscint, Inc. | 1998-04-02 |
| GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 (K974614) | Elscint, Inc. | 1998-03-04 |
| 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) (K972592) | Elscint, Inc. | 1997-09-15 |
| GLORY (K970680) | Elscint, Inc. | 1997-06-20 |
| GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 (K965044) | Elscint, Inc. | 1997-06-16 |