MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
FDA 510(k) clearance K962738 · decided 1996-10-10
Clearance details
- K-number
- K962738
- Device name
- MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-07-15
- Decision date
- 1996-10-10
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition Sy recall (Z-0369-2019) | GE Healthcare, LLC | 2018-11-14 |
| GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL recall (Z-0370-2019) | GE Healthcare, LLC | 2018-11-14 |
| GE Healthcare Millennium MC recall (Z-0371-2019) | GE Healthcare, LLC | 2018-11-14 |
| GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized n recall (Z-0413-06) | GE Healthcare | 2006-01-24 |
| GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modula recall (Z-0414-06) | GE Healthcare | 2006-01-24 |
| GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system i recall (Z-0415-06) | GE Healthcare | 2006-01-24 |