GYREX 2T-PRESTIGE
FDA 510(k) clearance K970005 · decided 1997-03-28
Clearance details
- K-number
- K970005
- Device name
- GYREX 2T-PRESTIGE
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-02
- Decision date
- 1997-03-28
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LNI
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hackensack, NJ, US
- Third-party review
- No
- Expedited review
- No
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| MR SPECTROSCOPY PACKAGE (K991568) | Philips Medical Systems (Cleveland), Inc. | 1999-07-19 |
| SAGE 7 (K984167) | GE Medical Systems | 1999-01-12 |
| CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (K962627) | Siemens Medical Solutions USA, Inc. | 1997-04-03 |
| HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT (K930265) | GE Medical Systems | 1995-04-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GYREX (P840007/S003) | Elscint, Inc. | 1988-04-26 |
| GYREX, MODELS S3500 & S5000 (P840007/S002) | Elscint, Inc. | 1987-10-08 |
| GYREX, MODELS S3500 & S5000 (P840007/S001) | Elscint, Inc. | 1987-04-02 |