VENTRI 1.1
FDA 510(k) clearance K080124 · decided 2008-01-31
Clearance details
- K-number
- K080124
- Device name
- VENTRI 1.1
- Applicant
- Ge Medical Systems F.I. Haifa
- Decision
- Substantially Equivalent
- Date received
- 2008-01-17
- Decision date
- 2008-01-31
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| System, Tomography Computed Emmission recall (Z-2259-2020) | GE Healthcare, LLC | 2020-06-03 |
| Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3 recall (Z-1168-2013) | GE Healthcare, LLC | 2013-04-24 |