TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
FDA 510(k) clearance K952674 · decided 1995-09-26
Clearance details
- K-number
- K952674
- Device name
- TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-12
- Decision date
- 1995-09-26
- Days to decision
- 106 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 Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac recall (Z-0290-2026) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2025-10-23 |
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 |