APEX HELIX - A
FDA 510(k) clearance K914807 · decided 1992-02-27
Clearance details
- K-number
- K914807
- Device name
- APEX HELIX - A
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-25
- Decision date
- 1992-02-27
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hackensack, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usag recall (Z-1789-2013) | GE Healthcare, LLC | 2013-07-24 |
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 |