2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
FDA 510(k) clearance K972592 · decided 1997-09-15
Clearance details
- K-number
- K972592
- Device name
- 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-11
- Decision date
- 1997-09-15
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MOS
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |